16 Regulatory Affairs Specialist jobs in London
Sr. Regulatory Affairs Specialist
London, London
Medtronic
Posted today
Job Viewed
Job Description
We anticipate the application window for this opening will close on - 19 Oct 2025
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youu2019ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youu2019ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
The Senior Regulatory Affairs Specialist role will both lead and support the review of advertising and promotional materials for MiniMed diabetes products across Europe, the Middle East, and Africa (EMEA), plus the UK and Ireland. This role ensures compliance with regional regulations, working closely with cross-functional teams (marketing, clinical, and international regulatory colleagues, consulting with legal when needed) to enable innovative and compliant product communication.
A remote based position in country or from the United States is possible, with travel to onsite meetings in North America about twice per year.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
Key responsibilities may include the following and other duties may be assigned.
Review and approve EMEA and UKI advertising and promotional materials for diabetes products ensuring compliance with local, regional, and international regulations.
Collaborate with regulatory, legal, marketing, and international regulatory teams to ensure clarity and accuracy of promotional claims.
Work with Medical Affairs to confirm and align claims according to clinical trial publications and clinical data.
Advise on regulatory requirements and best practices for product advertising and promotion in EMEA.
Monitor global regulatory changes and trends and competitor activity, proactively communicating changes to internal teams and contribute to updating processes.
Coordinate with regulatory specialist teammatesu2019 submissions and required documentation related to indications for use, regulator interactive review, etc.
Provide training and guidance to internal stakeholders on regulatory standards and company risk tolerance for advertising and promotion.
**Must Have: Minimum Requirements**
_To be considered for this role, please ensure the minimum requirements are evident in your applicant profile._
Bacheloru2019s degree in a scientific, healthcare, or regulatory-related field and 4+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.
OR
Advanced Degree in a scientific, healthcare, or regulatory-related field and 2+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.
**Nice to Have**
Advanced degree (Masteru2019s or equivalent).
Experience with diabetes-related products or devices.
4+ years of U.S. and EU regulatory submission experience (preferred 510(k) and Technical Documentation)
Proficient understanding of EU MDR, FDA requirements.
Knowledge of Medical Device Quality Systems
Experience working with international, cross-functional, and core-teams.
Product launch experience.
Understanding of corporate goals, product pipeline, disease state, customer needs, reimbursement, and competitive environment.
Experience with Agile, Veeva PromoMats.
Demonstrated experience in reviewing advertising and promotional materials in either Europe, United States, or Canada (EMEA experience preferred).
Strong knowledge of medical device regulations, including EU MDR, UK MHRA, US FDA and /or regional advertising standards.
Ability to interpret clinical data and publications in the context of promotional claims.
Exceptional attention to detail and strong communication skills.
Experience collaborating in cross-functional and international teams.
Strong oral and written communication skills.
Effective interpersonal skills.
Effective team member.
Proficient skills with MS Word, MS Outlook, MS Excel, MS PowerPoint.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.u202f
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD):$92,000.00 - $138,000.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans (
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission u2014 to alleviate pain, restore health, and extend life u2014 unites a global team of 95,000+ passionate people.
We are engineers at heartu2014 putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( .
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. (u201cMedtronicu201d) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here ( a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission u2014 to alleviate pain, restore health, and extend life u2014 unites a global team of 95,000+ passionate people.
We are engineers at heartu2014 putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. Thatu2019s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you willu2026
**Build** a better future, amplifying your impact on the causes that matter to you and the world
**Grow** a career reflective of your passion and abilities
**Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, itu2019s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare settingu202fis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youu2019ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youu2019ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
The Senior Regulatory Affairs Specialist role will both lead and support the review of advertising and promotional materials for MiniMed diabetes products across Europe, the Middle East, and Africa (EMEA), plus the UK and Ireland. This role ensures compliance with regional regulations, working closely with cross-functional teams (marketing, clinical, and international regulatory colleagues, consulting with legal when needed) to enable innovative and compliant product communication.
A remote based position in country or from the United States is possible, with travel to onsite meetings in North America about twice per year.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
Key responsibilities may include the following and other duties may be assigned.
Review and approve EMEA and UKI advertising and promotional materials for diabetes products ensuring compliance with local, regional, and international regulations.
Collaborate with regulatory, legal, marketing, and international regulatory teams to ensure clarity and accuracy of promotional claims.
Work with Medical Affairs to confirm and align claims according to clinical trial publications and clinical data.
Advise on regulatory requirements and best practices for product advertising and promotion in EMEA.
Monitor global regulatory changes and trends and competitor activity, proactively communicating changes to internal teams and contribute to updating processes.
Coordinate with regulatory specialist teammatesu2019 submissions and required documentation related to indications for use, regulator interactive review, etc.
Provide training and guidance to internal stakeholders on regulatory standards and company risk tolerance for advertising and promotion.
**Must Have: Minimum Requirements**
_To be considered for this role, please ensure the minimum requirements are evident in your applicant profile._
Bacheloru2019s degree in a scientific, healthcare, or regulatory-related field and 4+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.
OR
Advanced Degree in a scientific, healthcare, or regulatory-related field and 2+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.
**Nice to Have**
Advanced degree (Masteru2019s or equivalent).
Experience with diabetes-related products or devices.
4+ years of U.S. and EU regulatory submission experience (preferred 510(k) and Technical Documentation)
Proficient understanding of EU MDR, FDA requirements.
Knowledge of Medical Device Quality Systems
Experience working with international, cross-functional, and core-teams.
Product launch experience.
Understanding of corporate goals, product pipeline, disease state, customer needs, reimbursement, and competitive environment.
Experience with Agile, Veeva PromoMats.
Demonstrated experience in reviewing advertising and promotional materials in either Europe, United States, or Canada (EMEA experience preferred).
Strong knowledge of medical device regulations, including EU MDR, UK MHRA, US FDA and /or regional advertising standards.
Ability to interpret clinical data and publications in the context of promotional claims.
Exceptional attention to detail and strong communication skills.
Experience collaborating in cross-functional and international teams.
Strong oral and written communication skills.
Effective interpersonal skills.
Effective team member.
Proficient skills with MS Word, MS Outlook, MS Excel, MS PowerPoint.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.u202f
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD):$92,000.00 - $138,000.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans (
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission u2014 to alleviate pain, restore health, and extend life u2014 unites a global team of 95,000+ passionate people.
We are engineers at heartu2014 putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( .
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. (u201cMedtronicu201d) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here ( a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission u2014 to alleviate pain, restore health, and extend life u2014 unites a global team of 95,000+ passionate people.
We are engineers at heartu2014 putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. Thatu2019s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you willu2026
**Build** a better future, amplifying your impact on the causes that matter to you and the world
**Grow** a career reflective of your passion and abilities
**Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, itu2019s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare settingu202fis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
This advertiser has chosen not to accept applicants from your region.
0
Sr. Regulatory Affairs Specialist
London, London
Medtronic
Posted today
Job Viewed
Job Description
We anticipate the application window for this opening will close on - 19 Oct 2025
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youu2019ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youu2019ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
The Senior Regulatory Affairs Specialist role will both lead and support the review of advertising and promotional materials for MiniMed diabetes products across Europe, the Middle East, and Africa (EMEA), plus the UK and Ireland. This role ensures compliance with regional regulations, working closely with cross-functional teams (marketing, clinical, and international regulatory colleagues, consulting with legal when needed) to enable innovative and compliant product communication.
A remote based position in country or from the United States is possible, with travel to onsite meetings in North America about twice per year.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
Key responsibilities may include the following and other duties may be assigned.
Review and approve EMEA and UKI advertising and promotional materials for diabetes products ensuring compliance with local, regional, and international regulations.
Collaborate with regulatory, legal, marketing, and international regulatory teams to ensure clarity and accuracy of promotional claims.
Work with Medical Affairs to confirm and align claims according to clinical trial publications and clinical data.
Advise on regulatory requirements and best practices for product advertising and promotion in EMEA.
Monitor global regulatory changes and trends and competitor activity, proactively communicating changes to internal teams and contribute to updating processes.
Coordinate with regulatory specialist teammatesu2019 submissions and required documentation related to indications for use, regulator interactive review, etc.
Provide training and guidance to internal stakeholders on regulatory standards and company risk tolerance for advertising and promotion.
**Must Have: Minimum Requirements**
_To be considered for this role, please ensure the minimum requirements are evident in your applicant profile._
Bacheloru2019s degree in a scientific, healthcare, or regulatory-related field and 4+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.
OR
Advanced Degree in a scientific, healthcare, or regulatory-related field and 2+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.
**Nice to Have**
Advanced degree (Masteru2019s or equivalent).
Experience with diabetes-related products or devices.
4+ years of U.S. and EU regulatory submission experience (preferred 510(k) and Technical Documentation)
Proficient understanding of EU MDR, FDA requirements.
Knowledge of Medical Device Quality Systems
Experience working with international, cross-functional, and core-teams.
Product launch experience.
Understanding of corporate goals, product pipeline, disease state, customer needs, reimbursement, and competitive environment.
Experience with Agile, Veeva PromoMats.
Demonstrated experience in reviewing advertising and promotional materials in either Europe, United States, or Canada (EMEA experience preferred).
Strong knowledge of medical device regulations, including EU MDR, UK MHRA, US FDA and /or regional advertising standards.
Ability to interpret clinical data and publications in the context of promotional claims.
Exceptional attention to detail and strong communication skills.
Experience collaborating in cross-functional and international teams.
Strong oral and written communication skills.
Effective interpersonal skills.
Effective team member.
Proficient skills with MS Word, MS Outlook, MS Excel, MS PowerPoint.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.u202f
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD):$92,000.00 - $138,000.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans (
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission u2014 to alleviate pain, restore health, and extend life u2014 unites a global team of 95,000+ passionate people.
We are engineers at heartu2014 putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( .
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. (u201cMedtronicu201d) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here ( a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission u2014 to alleviate pain, restore health, and extend life u2014 unites a global team of 95,000+ passionate people.
We are engineers at heartu2014 putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. Thatu2019s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you willu2026
**Build** a better future, amplifying your impact on the causes that matter to you and the world
**Grow** a career reflective of your passion and abilities
**Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, itu2019s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare settingu202fis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youu2019ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youu2019ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
The Senior Regulatory Affairs Specialist role will both lead and support the review of advertising and promotional materials for MiniMed diabetes products across Europe, the Middle East, and Africa (EMEA), plus the UK and Ireland. This role ensures compliance with regional regulations, working closely with cross-functional teams (marketing, clinical, and international regulatory colleagues, consulting with legal when needed) to enable innovative and compliant product communication.
A remote based position in country or from the United States is possible, with travel to onsite meetings in North America about twice per year.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
Key responsibilities may include the following and other duties may be assigned.
Review and approve EMEA and UKI advertising and promotional materials for diabetes products ensuring compliance with local, regional, and international regulations.
Collaborate with regulatory, legal, marketing, and international regulatory teams to ensure clarity and accuracy of promotional claims.
Work with Medical Affairs to confirm and align claims according to clinical trial publications and clinical data.
Advise on regulatory requirements and best practices for product advertising and promotion in EMEA.
Monitor global regulatory changes and trends and competitor activity, proactively communicating changes to internal teams and contribute to updating processes.
Coordinate with regulatory specialist teammatesu2019 submissions and required documentation related to indications for use, regulator interactive review, etc.
Provide training and guidance to internal stakeholders on regulatory standards and company risk tolerance for advertising and promotion.
**Must Have: Minimum Requirements**
_To be considered for this role, please ensure the minimum requirements are evident in your applicant profile._
Bacheloru2019s degree in a scientific, healthcare, or regulatory-related field and 4+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.
OR
Advanced Degree in a scientific, healthcare, or regulatory-related field and 2+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.
**Nice to Have**
Advanced degree (Masteru2019s or equivalent).
Experience with diabetes-related products or devices.
4+ years of U.S. and EU regulatory submission experience (preferred 510(k) and Technical Documentation)
Proficient understanding of EU MDR, FDA requirements.
Knowledge of Medical Device Quality Systems
Experience working with international, cross-functional, and core-teams.
Product launch experience.
Understanding of corporate goals, product pipeline, disease state, customer needs, reimbursement, and competitive environment.
Experience with Agile, Veeva PromoMats.
Demonstrated experience in reviewing advertising and promotional materials in either Europe, United States, or Canada (EMEA experience preferred).
Strong knowledge of medical device regulations, including EU MDR, UK MHRA, US FDA and /or regional advertising standards.
Ability to interpret clinical data and publications in the context of promotional claims.
Exceptional attention to detail and strong communication skills.
Experience collaborating in cross-functional and international teams.
Strong oral and written communication skills.
Effective interpersonal skills.
Effective team member.
Proficient skills with MS Word, MS Outlook, MS Excel, MS PowerPoint.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.u202f
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD):$92,000.00 - $138,000.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans (
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission u2014 to alleviate pain, restore health, and extend life u2014 unites a global team of 95,000+ passionate people.
We are engineers at heartu2014 putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( .
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. (u201cMedtronicu201d) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here ( a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission u2014 to alleviate pain, restore health, and extend life u2014 unites a global team of 95,000+ passionate people.
We are engineers at heartu2014 putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. Thatu2019s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you willu2026
**Build** a better future, amplifying your impact on the causes that matter to you and the world
**Grow** a career reflective of your passion and abilities
**Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, itu2019s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare settingu202fis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
This advertiser has chosen not to accept applicants from your region.
1
Sr. Regulatory Affairs Specialist
London, London
Medtronic
Posted today
Job Viewed
Job Description
We anticipate the application window for this opening will close on - 19 Oct 2025
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
The Senior Regulatory Affairs Specialist role will both lead and support the review of advertising and promotional materials for MiniMed diabetes products across Europe, the Middle East, and Africa (EMEA), plus the UK and Ireland. This role ensures compliance with regional regulations, working closely with cross-functional teams (marketing, clinical, and international regulatory colleagues, consulting with legal when needed) to enable innovative and compliant product communication.
A remote based position in country or from the United States is possible, with travel to onsite meetings in North America about twice per year.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
Key responsibilities may include the following and other duties may be assigned.
+ Review and approve EMEA and UKI advertising and promotional materials for diabetes products ensuring compliance with local, regional, and international regulations.
+ Collaborate with regulatory, legal, marketing, and international regulatory teams to ensure clarity and accuracy of promotional claims.
+ Work with Medical Affairs to confirm and align claims according to clinical trial publications and clinical data.
+ Advise on regulatory requirements and best practices for product advertising and promotion in EMEA.
+ Monitor global regulatory changes and trends and competitor activity, proactively communicating changes to internal teams and contribute to updating processes.
+ Coordinate with regulatory specialist teammates' submissions and required documentation related to indications for use, regulator interactive review, etc.
+ Provide training and guidance to internal stakeholders on regulatory standards and company risk tolerance for advertising and promotion.
**Must Have: Minimum Requirements**
_To be considered for this role, please ensure the minimum requirements are evident in your applicant profile._
Bachelor's degree in a scientific, healthcare, or regulatory-related field and 4+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.
OR
Advanced Degree in a scientific, healthcare, or regulatory-related field and 2+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.
**Nice to Have**
+ Advanced degree (Master's or equivalent).
+ Experience with diabetes-related products or devices.
+ 4+ years of U.S. and EU regulatory submission experience (preferred 510(k) and Technical Documentation)
+ Proficient understanding of EU MDR, FDA requirements.
+ Knowledge of Medical Device Quality Systems
+ Experience working with international, cross-functional, and core-teams.
+ Product launch experience.
+ Understanding of corporate goals, product pipeline, disease state, customer needs, reimbursement, and competitive environment.
+ Experience with Agile, Veeva PromoMats.
+ Demonstrated experience in reviewing advertising and promotional materials in either Europe, United States, or Canada (EMEA experience preferred).
+ Strong knowledge of medical device regulations, including EU MDR, UK MHRA, US FDA and /or regional advertising standards.
+ Ability to interpret clinical data and publications in the context of promotional claims.
+ Exceptional attention to detail and strong communication skills.
+ Experience collaborating in cross-functional and international teams.
+ Strong oral and written communication skills.
+ Effective interpersonal skills.
+ Effective team member.
+ Proficient skills with MS Word, MS Outlook, MS Excel, MS PowerPoint.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD):$92,000.00 - $138,000.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans ( Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( .
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here ( a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
The Senior Regulatory Affairs Specialist role will both lead and support the review of advertising and promotional materials for MiniMed diabetes products across Europe, the Middle East, and Africa (EMEA), plus the UK and Ireland. This role ensures compliance with regional regulations, working closely with cross-functional teams (marketing, clinical, and international regulatory colleagues, consulting with legal when needed) to enable innovative and compliant product communication.
A remote based position in country or from the United States is possible, with travel to onsite meetings in North America about twice per year.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
Key responsibilities may include the following and other duties may be assigned.
+ Review and approve EMEA and UKI advertising and promotional materials for diabetes products ensuring compliance with local, regional, and international regulations.
+ Collaborate with regulatory, legal, marketing, and international regulatory teams to ensure clarity and accuracy of promotional claims.
+ Work with Medical Affairs to confirm and align claims according to clinical trial publications and clinical data.
+ Advise on regulatory requirements and best practices for product advertising and promotion in EMEA.
+ Monitor global regulatory changes and trends and competitor activity, proactively communicating changes to internal teams and contribute to updating processes.
+ Coordinate with regulatory specialist teammates' submissions and required documentation related to indications for use, regulator interactive review, etc.
+ Provide training and guidance to internal stakeholders on regulatory standards and company risk tolerance for advertising and promotion.
**Must Have: Minimum Requirements**
_To be considered for this role, please ensure the minimum requirements are evident in your applicant profile._
Bachelor's degree in a scientific, healthcare, or regulatory-related field and 4+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.
OR
Advanced Degree in a scientific, healthcare, or regulatory-related field and 2+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.
**Nice to Have**
+ Advanced degree (Master's or equivalent).
+ Experience with diabetes-related products or devices.
+ 4+ years of U.S. and EU regulatory submission experience (preferred 510(k) and Technical Documentation)
+ Proficient understanding of EU MDR, FDA requirements.
+ Knowledge of Medical Device Quality Systems
+ Experience working with international, cross-functional, and core-teams.
+ Product launch experience.
+ Understanding of corporate goals, product pipeline, disease state, customer needs, reimbursement, and competitive environment.
+ Experience with Agile, Veeva PromoMats.
+ Demonstrated experience in reviewing advertising and promotional materials in either Europe, United States, or Canada (EMEA experience preferred).
+ Strong knowledge of medical device regulations, including EU MDR, UK MHRA, US FDA and /or regional advertising standards.
+ Ability to interpret clinical data and publications in the context of promotional claims.
+ Exceptional attention to detail and strong communication skills.
+ Experience collaborating in cross-functional and international teams.
+ Strong oral and written communication skills.
+ Effective interpersonal skills.
+ Effective team member.
+ Proficient skills with MS Word, MS Outlook, MS Excel, MS PowerPoint.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD):$92,000.00 - $138,000.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans ( Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( .
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here ( a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
This advertiser has chosen not to accept applicants from your region.
2
Senior Regulatory Affairs Specialist
SW1A 0AA London, London
£70000 Annually
WhatJobs
Posted 7 days ago
Job Viewed
Job Description
Our client, a leading and innovative pharmaceutical company, is seeking a highly experienced Senior Regulatory Affairs Specialist to join their esteemed team in **London, England, UK**. This role operates on a hybrid model, offering a blend of in-office collaboration and remote working flexibility.
As a Senior Regulatory Affairs Specialist, you will be responsible for developing and implementing regulatory strategies for new and existing pharmaceutical products. You will ensure compliance with global regulatory requirements, manage the preparation and submission of regulatory dossiers, and serve as a key liaison with health authorities. This position requires a deep understanding of pharmaceutical regulatory landscapes, excellent scientific acumen, and strong project management skills. You will play a crucial role in bringing life-changing medicines to market efficiently and effectively.
Key Responsibilities:
Qualifications and Experience:
This is an excellent opportunity for a dedicated Regulatory Affairs professional to make a significant contribution to a dynamic pharmaceutical organization and enjoy a rewarding hybrid working arrangement.
As a Senior Regulatory Affairs Specialist, you will be responsible for developing and implementing regulatory strategies for new and existing pharmaceutical products. You will ensure compliance with global regulatory requirements, manage the preparation and submission of regulatory dossiers, and serve as a key liaison with health authorities. This position requires a deep understanding of pharmaceutical regulatory landscapes, excellent scientific acumen, and strong project management skills. You will play a crucial role in bringing life-changing medicines to market efficiently and effectively.
Key Responsibilities:
- Develop and execute comprehensive regulatory affairs strategies for assigned products throughout their lifecycle.
- Prepare, review, and submit regulatory dossiers (e.g., CTAs, INDs, NDAs, MAAs) to global health authorities (FDA, EMA, MHRA, etc.).
- Serve as the primary contact with regulatory agencies, managing communications and responding to queries.
- Provide regulatory guidance and support to internal R&D, clinical, manufacturing, and marketing teams.
- Interpret and advise on complex regulatory requirements and guidelines.
- Monitor the regulatory environment for changes and assess their impact on company products and strategies.
- Manage post-approval regulatory activities, including supplements, variations, and annual reports.
- Conduct regulatory intelligence activities and contribute to the development of regulatory policies and procedures.
- Review promotional and advertising materials for regulatory compliance.
- Lead regulatory strategy meetings and provide training to relevant personnel.
- Ensure compliance with GxP regulations and company quality standards.
Qualifications and Experience:
- A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
- A minimum of 6-8 years of progressive experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting various types of regulatory applications.
- In-depth knowledge of global regulatory requirements and guidelines (e.g., ICH, FDA, EMA).
- Strong understanding of drug development processes from pre-clinical to post-market.
- Excellent scientific writing, communication, and interpersonal skills.
- Proven ability to manage multiple projects simultaneously and meet tight deadlines.
- Experience working collaboratively with cross-functional teams.
- Proficiency in regulatory information management systems and standard office software.
- Ability to work effectively in a hybrid work environment.
This is an excellent opportunity for a dedicated Regulatory Affairs professional to make a significant contribution to a dynamic pharmaceutical organization and enjoy a rewarding hybrid working arrangement.
This advertiser has chosen not to accept applicants from your region.
3
Senior Regulatory Affairs Specialist, Pharma
SW1A 0AA London, London
£75000 Annually
WhatJobs
Posted 18 days ago
Job Viewed
Job Description
Our client, a rapidly expanding pharmaceutical company, is seeking a highly skilled Senior Regulatory Affairs Specialist to join their global team. This is a fully remote position, offering the flexibility to work from anywhere within the UK. You will be responsible for managing the regulatory submission process for new pharmaceutical products and variations, ensuring compliance with international regulations, and liaising with health authorities. This role demands an in-depth understanding of pharmaceutical regulations, excellent project management skills, and the ability to navigate complex regulatory landscapes from a remote setting.
Responsibilities:
Responsibilities:
- Develop and implement global regulatory strategies for product registration and lifecycle management.
- Prepare, review, and submit regulatory dossiers (e.g., CTD, eCTD) to health authorities worldwide (e.g., EMA, FDA, MHRA).
- Manage responses to queries from regulatory agencies and ensure timely resolution.
- Stay abreast of evolving regulatory requirements and guidance documents, and assess their impact on company products.
- Provide regulatory guidance and support to R&D, clinical, manufacturing, and marketing departments.
- Evaluate proposed changes to product labelling, manufacturing processes, and clinical trial protocols from a regulatory perspective.
- Conduct regulatory intelligence gathering and competitor analysis.
- Manage relationships with external consultants and contract research organisations (CROs) involved in regulatory submissions.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).
- Contribute to the development of regulatory policies and procedures.
- Lead regulatory aspects of product divestitures or acquisitions as needed.
- Mentor junior regulatory affairs professionals.
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.
- Minimum of 7 years of experience in pharmaceutical regulatory affairs, with a strong focus on international submissions.
- Proven track record of successfully preparing and submitting regulatory dossiers to major health authorities.
- In-depth knowledge of pharmaceutical regulations (e.g., ICH guidelines, EU regulations, FDA regulations).
- Experience with eCTD submission software and regulatory information management (RIM) systems.
- Excellent written and verbal communication skills, with strong attention to detail.
- Strong analytical and problem-solving abilities.
- Ability to manage multiple projects simultaneously and meet tight deadlines.
- Proficiency in project management and cross-functional team collaboration.
- Experience in a specific therapeutic area is a plus.
- Fluency in English is essential; knowledge of other languages is an advantage.
This advertiser has chosen not to accept applicants from your region.
4
Sr Mgr Regulatory Affairs
Uxbridge, London
Regeneron Pharmaceuticals
Posted 13 days ago
Job Viewed
Job Description
At Regeneron, we're advancing science and medicine to improve lives. We're seeking a talented Regulatory Affairs Manager to join our team and play a pivotal role in supporting EU regulatory activities for oncology drug development. This is your chance to contribute to groundbreaking clinical development programs while collaborating with global experts and building relationships across the EU regulatory network.
Join us in shaping the future of oncology treatments and making a meaningful impact on patients' lives.
**A Typical Day:**
As a Regulatory Affairs Manager, your day might include:
+ Developing regulatory strategies for oncology programs by researching guidelines, EU precedents, and emerging trends.
+ Managing CTA submissions via CTIS for multiple EU member states, ensuring compliance with EU requirements.
+ Organizing, preparing, and reviewing CTA amendments, annual reports, and other regulatory documents.
+ Performing critical analyses of clinical and preclinical data to develop interpretations and conclusions.
+ Leading EU Scientific Advice requests and coordinating EMA and EU national agency meetings.
+ Monitoring newly published EU Commission and EMA guidelines to ensure compliance and provide training for scientific staff.
+ Representing Regeneron Regulatory Affairs in engagements with EMA scientific committees, EU national agencies, and industry associations.
**This Role May Be For You If:**
You are someone who:
+ Thrives in a collaborative environment and enjoys working with multidisciplinary teams.
+ Has a proven ability to navigate EU regulatory frameworks and requirements.
+ Is detail-oriented and skilled in analyzing clinical and preclinical data.
+ Has experience leading regulatory agency meetings and negotiating effectively with stakeholders.
+ Is passionate about contributing to oncology drug development programs.
+ Values continuous learning and stays updated on emerging regulatory trends.
+ Has excellent written and verbal communication skills.
**To Be Considered:**
We're looking for candidates with:
+ An advanced degree in a scientific discipline.
+ At least 4 years of regulatory experience, with a focus on clinical development.
+ Proven experience supporting EU Clinical Trial Applications through approval and study start-up.
+ Familiarity with EMA processes such as scientific advice, orphan designation, and PIPs.
+ Experience in oncology regulatory strategy is an advantage.
+ A strong ability to negotiate and express clear positions to stakeholders at all levels.
+ Preferred qualifications include experience with marketing authorization applications or life-cycle management of approved products in the centralized procedure.
**Why Join Us?**
At Regeneron, we believe in fostering innovation, collaboration, and growth. You'll have the opportunity to work with a passionate team dedicated to advancing science and improving patient outcomes. Together, we'll make a difference.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Join us in shaping the future of oncology treatments and making a meaningful impact on patients' lives.
**A Typical Day:**
As a Regulatory Affairs Manager, your day might include:
+ Developing regulatory strategies for oncology programs by researching guidelines, EU precedents, and emerging trends.
+ Managing CTA submissions via CTIS for multiple EU member states, ensuring compliance with EU requirements.
+ Organizing, preparing, and reviewing CTA amendments, annual reports, and other regulatory documents.
+ Performing critical analyses of clinical and preclinical data to develop interpretations and conclusions.
+ Leading EU Scientific Advice requests and coordinating EMA and EU national agency meetings.
+ Monitoring newly published EU Commission and EMA guidelines to ensure compliance and provide training for scientific staff.
+ Representing Regeneron Regulatory Affairs in engagements with EMA scientific committees, EU national agencies, and industry associations.
**This Role May Be For You If:**
You are someone who:
+ Thrives in a collaborative environment and enjoys working with multidisciplinary teams.
+ Has a proven ability to navigate EU regulatory frameworks and requirements.
+ Is detail-oriented and skilled in analyzing clinical and preclinical data.
+ Has experience leading regulatory agency meetings and negotiating effectively with stakeholders.
+ Is passionate about contributing to oncology drug development programs.
+ Values continuous learning and stays updated on emerging regulatory trends.
+ Has excellent written and verbal communication skills.
**To Be Considered:**
We're looking for candidates with:
+ An advanced degree in a scientific discipline.
+ At least 4 years of regulatory experience, with a focus on clinical development.
+ Proven experience supporting EU Clinical Trial Applications through approval and study start-up.
+ Familiarity with EMA processes such as scientific advice, orphan designation, and PIPs.
+ Experience in oncology regulatory strategy is an advantage.
+ A strong ability to negotiate and express clear positions to stakeholders at all levels.
+ Preferred qualifications include experience with marketing authorization applications or life-cycle management of approved products in the centralized procedure.
**Why Join Us?**
At Regeneron, we believe in fostering innovation, collaboration, and growth. You'll have the opportunity to work with a passionate team dedicated to advancing science and improving patient outcomes. Together, we'll make a difference.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
This advertiser has chosen not to accept applicants from your region.
5
Director, Regulatory Affairs, Pre-Market
London, London
GE HealthCare
Posted today
Job Viewed
Job Description
**Job Description Summary**
Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Interprets simple internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.
**Job Description**
**Roles and Responsibilities**
+ **Leadership & Strategy**
+ Lead and develop the European Regulatory Affairs team, fostering a high-performance and collaborative culture.
+ Define and execute regulatory strategies aligned with GE HealthCare's global objectives.
+ Represent Regulatory Affairs in cross-functional leadership forums and strategic initiatives.
+ **Regulatory Compliance**
+ Ensure compliance with EU MDR and other applicable European regulations.
+ Act as PRRC under MDR, ensuring product conformity and regulatory documentation integrity.
+ Oversee regulatory submissions, CE marking processes, and interactions with Notified Bodies and Competent Authorities.
+ **Operational Excellence**
+ Drive continuous improvement in regulatory processes and systems.
+ Monitor regulatory changes and assess impact on GE HealthCare's product portfolio.
+ Support audits, inspections, and regulatory due diligence activities.
+ **Stakeholder Engagement**
+ Collaborate with Quality, Legal, Commercial, and Product teams to ensure regulatory alignment.
+ Provide expert guidance and training on European regulatory requirements.
+ Represent GE HealthCare in industry associations and regulatory forums as needed.
**Required Qualifications**
+ Bachelor's or Master's degree in Life Sciences, Engineering, or related field.
+ Minimum 10 years of experience in Regulatory Affairs, with significant exposure to European medical device regulations.
+ Proven leadership experience, including team management and strategic planning.
+ Fluent in German and English (written and spoken).
+ Must be based in the European Union and meet the qualifications to act as PRRC under MDR.
+ Strong knowledge of EU MDR, IVDR, and relevant guidance documents.
+ Excellent communication, negotiation, and stakeholder management skills.
**Desired Characteristics**
+ Experience working in a global or matrixed organization.
+ Familiarity with digital health technologies and software as a medical device (SaMD).
+ Ability to influence and lead through change.
#LI-AO1
#LI-Hybrid
**Additional Information**
**Relocation Assistance Provided:** No
Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Interprets simple internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.
**Job Description**
**Roles and Responsibilities**
+ **Leadership & Strategy**
+ Lead and develop the European Regulatory Affairs team, fostering a high-performance and collaborative culture.
+ Define and execute regulatory strategies aligned with GE HealthCare's global objectives.
+ Represent Regulatory Affairs in cross-functional leadership forums and strategic initiatives.
+ **Regulatory Compliance**
+ Ensure compliance with EU MDR and other applicable European regulations.
+ Act as PRRC under MDR, ensuring product conformity and regulatory documentation integrity.
+ Oversee regulatory submissions, CE marking processes, and interactions with Notified Bodies and Competent Authorities.
+ **Operational Excellence**
+ Drive continuous improvement in regulatory processes and systems.
+ Monitor regulatory changes and assess impact on GE HealthCare's product portfolio.
+ Support audits, inspections, and regulatory due diligence activities.
+ **Stakeholder Engagement**
+ Collaborate with Quality, Legal, Commercial, and Product teams to ensure regulatory alignment.
+ Provide expert guidance and training on European regulatory requirements.
+ Represent GE HealthCare in industry associations and regulatory forums as needed.
**Required Qualifications**
+ Bachelor's or Master's degree in Life Sciences, Engineering, or related field.
+ Minimum 10 years of experience in Regulatory Affairs, with significant exposure to European medical device regulations.
+ Proven leadership experience, including team management and strategic planning.
+ Fluent in German and English (written and spoken).
+ Must be based in the European Union and meet the qualifications to act as PRRC under MDR.
+ Strong knowledge of EU MDR, IVDR, and relevant guidance documents.
+ Excellent communication, negotiation, and stakeholder management skills.
**Desired Characteristics**
+ Experience working in a global or matrixed organization.
+ Familiarity with digital health technologies and software as a medical device (SaMD).
+ Ability to influence and lead through change.
#LI-AO1
#LI-Hybrid
**Additional Information**
**Relocation Assistance Provided:** No
This advertiser has chosen not to accept applicants from your region.
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About the latest Regulatory affairs specialist Jobs in London !
6
Associate Director, Regulatory Affairs, Oncology
Uxbridge, London
Gilead Sciences, Inc.
Posted 6 days ago
Job Viewed
Job Description
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**POSITION OVERVIEW:**
You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects in the assigned therapeutic (TA) area. You will typically be assigned multiple products or projects to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and sub-teams. You will typically serve as a Gilead contact to / for regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labelling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities. You will also play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities.
**RESPONSIBILITIES:**
+ As needed, represents Gilead in negotiations with regulatory authorities.
+ Makes significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies and capabilities.
+ Represents Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.
+ May participate on other Sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers) or assign such to other colleagues and oversee and guide their sub-team participation.
+ Defines the regulatory strategy for multiple Gilead products or projects.
+ Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plan.
+ Oversees and guides the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for commercial or investigational product(s). Examples include meeting requests, briefing packages, original Investigational New Drug (IND), IND amendment, and routine submissions (e.g., Development Safety Update Reports / DSURs, Investigator Brochure/ IB updates, etc.).
+ Oversees and approves the authoring of regulatory documents, including meeting requests, Module 1 documents for original IND, etc.
+ Oversees and guides labeling, packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets.
+ Critically reviews documents for submission to regulatory authorities.
+ Provides matrix management and leadership to project teams.
+ Provides accurate and thorough input and recommendations into resource plans required to complete own deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets.
+ Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
**REQUIREMENTS:**
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
**Rest of World Education & Experience**
BA/BSC or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Experience leading a broad range of regulatory activities and setting the regulatory strategy for biopharmaceutical products.
**Knowledge & Other Requirements**
+ In-depth understanding of U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards for medicinal products. Understands varying regional or country regulatory requirements for assigned markets.
+ In-depth knowledge of current global and regional trends in biopharmaceutical regulatory affairs. Proven effectiveness applying this knowledge to optimize team deliverables and results.
+ Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on its regulatory implications.
+ In-depth knowledge of relevant health authorities (HAs), including people, system, processes and requirements, as evidenced by past effectiveness and successes in conducting HA interactions.
+ Able to represent Gilead to regulatory authorities when managing standard and non-standard negotiations.
+ Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing.
+ Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
+ Strong interpersonal skills and understanding of team dynamics.
+ Strong communication and organizational skills.
+ Strong negotiation and conflict resolution skills.
+ When needed, ability to travel.
**Equal Employment Opportunity (EEO)**
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**POSITION OVERVIEW:**
You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects in the assigned therapeutic (TA) area. You will typically be assigned multiple products or projects to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and sub-teams. You will typically serve as a Gilead contact to / for regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labelling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities. You will also play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities.
**RESPONSIBILITIES:**
+ As needed, represents Gilead in negotiations with regulatory authorities.
+ Makes significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies and capabilities.
+ Represents Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.
+ May participate on other Sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers) or assign such to other colleagues and oversee and guide their sub-team participation.
+ Defines the regulatory strategy for multiple Gilead products or projects.
+ Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plan.
+ Oversees and guides the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for commercial or investigational product(s). Examples include meeting requests, briefing packages, original Investigational New Drug (IND), IND amendment, and routine submissions (e.g., Development Safety Update Reports / DSURs, Investigator Brochure/ IB updates, etc.).
+ Oversees and approves the authoring of regulatory documents, including meeting requests, Module 1 documents for original IND, etc.
+ Oversees and guides labeling, packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets.
+ Critically reviews documents for submission to regulatory authorities.
+ Provides matrix management and leadership to project teams.
+ Provides accurate and thorough input and recommendations into resource plans required to complete own deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets.
+ Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
**REQUIREMENTS:**
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
**Rest of World Education & Experience**
BA/BSC or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Experience leading a broad range of regulatory activities and setting the regulatory strategy for biopharmaceutical products.
**Knowledge & Other Requirements**
+ In-depth understanding of U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards for medicinal products. Understands varying regional or country regulatory requirements for assigned markets.
+ In-depth knowledge of current global and regional trends in biopharmaceutical regulatory affairs. Proven effectiveness applying this knowledge to optimize team deliverables and results.
+ Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on its regulatory implications.
+ In-depth knowledge of relevant health authorities (HAs), including people, system, processes and requirements, as evidenced by past effectiveness and successes in conducting HA interactions.
+ Able to represent Gilead to regulatory authorities when managing standard and non-standard negotiations.
+ Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing.
+ Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
+ Strong interpersonal skills and understanding of team dynamics.
+ Strong communication and organizational skills.
+ Strong negotiation and conflict resolution skills.
+ When needed, ability to travel.
**Equal Employment Opportunity (EEO)**
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
This advertiser has chosen not to accept applicants from your region.
7
EU Regulatory Affairs Senior Manager - Oncology
Uxbridge, London
Amgen
Posted 13 days ago
Job Viewed
Job Description
**HOW MIGHT YOU DEFY IMAGINATION?**
If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.
**SENIOR REGULATORY AFFAIRS MANAGER**
**LIVE**
**What you will do**
In this vital role you will work to ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products.
Representing the EU region, you will be responsible for advising the GRT on regional considerations in developing strategy, and ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
+ Develop and execute regional regulatory product strategies, including precedence, risk management and contingency planning
+ Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements
+ Implement product related regulatory strategies, Regulatory Affairs processes and activity planning
+ Lead development of regional regulatory documents and meetings in accordance with GRT strategy
+ Provide regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plan)
+ Consistent with GRT strategy, advise on regulatory implications and requirements related to global clinical development plans and objectives
+ Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately
**Be part of our team**
You would be joining the European Regulatory team, part of the Global Regulatory Affairs function in Europe. You would be responsible for leading the European regulatory strategies and submissions for development and marketed products from first in human clinical trials to marketing authorisation, and throughout the products lifecycle.
This team is leading the regulatory activities for established products and also development assets.
**WIN**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
+ Degree educated in a scientific discipline
+ Extensive experience in regional regulatory environment
+ Proven track record of developing and executing regional regulatory strategy
+ In-depth understanding of the drug life cycle and development process from a regulatory perspective
+ In-depth understanding of the registration procedures in region for MA, post approval changes, extensions and renewals.
+ Ability to lead teams and work collaboratively in a dynamic environment
+ Proactive approach to problem solving
+ Ability to understand and communicate scientific/clinical information
+ Ability to anticipate regulatory agency expectations
+ Strong awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development
**THRIVE**
**What you can expect of us**
As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
+ Growth opportunities to learn and move up and across our global organization
+ Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
+ Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
**LOCATION:** Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.
**APPLY NOW**
**for a career that defies imagination**
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
**careers.amgen.com**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.
**SENIOR REGULATORY AFFAIRS MANAGER**
**LIVE**
**What you will do**
In this vital role you will work to ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products.
Representing the EU region, you will be responsible for advising the GRT on regional considerations in developing strategy, and ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
+ Develop and execute regional regulatory product strategies, including precedence, risk management and contingency planning
+ Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements
+ Implement product related regulatory strategies, Regulatory Affairs processes and activity planning
+ Lead development of regional regulatory documents and meetings in accordance with GRT strategy
+ Provide regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plan)
+ Consistent with GRT strategy, advise on regulatory implications and requirements related to global clinical development plans and objectives
+ Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately
**Be part of our team**
You would be joining the European Regulatory team, part of the Global Regulatory Affairs function in Europe. You would be responsible for leading the European regulatory strategies and submissions for development and marketed products from first in human clinical trials to marketing authorisation, and throughout the products lifecycle.
This team is leading the regulatory activities for established products and also development assets.
**WIN**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
+ Degree educated in a scientific discipline
+ Extensive experience in regional regulatory environment
+ Proven track record of developing and executing regional regulatory strategy
+ In-depth understanding of the drug life cycle and development process from a regulatory perspective
+ In-depth understanding of the registration procedures in region for MA, post approval changes, extensions and renewals.
+ Ability to lead teams and work collaboratively in a dynamic environment
+ Proactive approach to problem solving
+ Ability to understand and communicate scientific/clinical information
+ Ability to anticipate regulatory agency expectations
+ Strong awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development
**THRIVE**
**What you can expect of us**
As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
+ Growth opportunities to learn and move up and across our global organization
+ Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
+ Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
**LOCATION:** Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.
**APPLY NOW**
**for a career that defies imagination**
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
**careers.amgen.com**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
This advertiser has chosen not to accept applicants from your region.
8
Regulatory Affairs Liaisons Manager- Global Therapeutic Area (TA)
Uxbridge, London
Gilead Sciences, Inc.
Posted 13 days ago
Job Viewed
Job Description
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**POSITION OVERVIEW:**
The global regulatory affairs team is responsible for supporting Gilead to make sound strategic decisions to enable access for patients to our molecules.
The position is in the Virology IC/GPS regulatory franchise which is responsible for Intercontinental and Gilead Patient Solutions, working across territories throughout Asia, Latin America, Africa, Eastern Europe and the Middle East.
Working within the global team, you will support defining the regulatory strategy, plans and objectives for assigned products or projects. Your responsibilities will involve managing regulatory submissions and other projects, representing the IC/GPS regulatory franchise on cross-functional core and sub-teams.
As a Regional Regulatory Lead of products in the virology therapeutic area you will typically be assigned multiple products or projects to lead, manage and oversee simultaneously.
You will provide strategic and technical advice from development throughout the whole product lifecycle for all HIV, Hepatitis and Emerging Viruses projects/products.
Activities will include preparing and maintaining regulatory submissions, regulatory labelling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities.
You will work cross-functionally with a diverse number of stakeholders both internally and externally to Gilead.
**EXAMPLE RESPONSIBILITIES:**
+ Managing and leading regulatory strategies for designated products in the region. This ranges from new product licenses to lifecycle activities and includes oversight of all regulatory aspects of the application.
+ Preparation of regulatory submissions for products in the virology therapeutic area and execution of agreed strategies within the region.
+ Partner both within regulatory affairs and throughout the development and commercial organization. Collaborate with cross-functional partners to ensure optimal execution of the agreed regulatory strategy.
+ Establish strong relationships with Gilead affiliates and distributor partners and serve as point person for knowledge for their product to these key stakeholders.
+ Have a good understanding of the regulatory environment leveraging internal knowledge and external regulatory intelligence.
+ Preparation and maintenance of labelling to support MAAs and other post-licensing activities. Ensure that any updates to the Product Company Core Data Sheet (CCDS) are implemented in a timely manner.
+ Liaise with regulatory, manufacturing, and other parties as appropriate, to ensure that updates to the product packaging components are implemented in line with approved labelling in line with agreed timelines.
+ Participate and contribute to regulatory team meetings and be recognized as a knowledgeable resource for Regulatory Affairs in other departments.
+ May participate and lead collaborative efforts across function in process improvement initiatives.
+ Use internal electronic systems for planning, preparing, tracking and storing submissions to regulatory agencies.
**REQUIREMENTS:**
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
**Education & Experience**
BA/BS or advanced degree in life sciences or related field with regulatory experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Experience a broad range of regulatory activities and setting the regulatory strategy for biopharmaceutical products.
**Knowledge & Other Requirements**
+ A good working regulatory knowledge, including ICH and regional requirements.
+ An appreciation of current global and regional trends in Regulatory Affairs with proven effectiveness in applying this knowledge to optimize team deliverables.
+ Previous experience of working with emerging markets and/or in the Virology therapeutic area would be an advantage but not essential.
+ Methodical attention to detail.
+ Must have a "can do" attitude and be "hands on" as and when required.
+ Proven track record to manage, formulate and execute strategy.
+ Strong interpersonal skills and understanding of team dynamics.
+ Strong communication and organizational skills.
+ Strong negotiation and conflict resolution skills.
**Equal Employment Opportunity (EEO)**
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**POSITION OVERVIEW:**
The global regulatory affairs team is responsible for supporting Gilead to make sound strategic decisions to enable access for patients to our molecules.
The position is in the Virology IC/GPS regulatory franchise which is responsible for Intercontinental and Gilead Patient Solutions, working across territories throughout Asia, Latin America, Africa, Eastern Europe and the Middle East.
Working within the global team, you will support defining the regulatory strategy, plans and objectives for assigned products or projects. Your responsibilities will involve managing regulatory submissions and other projects, representing the IC/GPS regulatory franchise on cross-functional core and sub-teams.
As a Regional Regulatory Lead of products in the virology therapeutic area you will typically be assigned multiple products or projects to lead, manage and oversee simultaneously.
You will provide strategic and technical advice from development throughout the whole product lifecycle for all HIV, Hepatitis and Emerging Viruses projects/products.
Activities will include preparing and maintaining regulatory submissions, regulatory labelling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities.
You will work cross-functionally with a diverse number of stakeholders both internally and externally to Gilead.
**EXAMPLE RESPONSIBILITIES:**
+ Managing and leading regulatory strategies for designated products in the region. This ranges from new product licenses to lifecycle activities and includes oversight of all regulatory aspects of the application.
+ Preparation of regulatory submissions for products in the virology therapeutic area and execution of agreed strategies within the region.
+ Partner both within regulatory affairs and throughout the development and commercial organization. Collaborate with cross-functional partners to ensure optimal execution of the agreed regulatory strategy.
+ Establish strong relationships with Gilead affiliates and distributor partners and serve as point person for knowledge for their product to these key stakeholders.
+ Have a good understanding of the regulatory environment leveraging internal knowledge and external regulatory intelligence.
+ Preparation and maintenance of labelling to support MAAs and other post-licensing activities. Ensure that any updates to the Product Company Core Data Sheet (CCDS) are implemented in a timely manner.
+ Liaise with regulatory, manufacturing, and other parties as appropriate, to ensure that updates to the product packaging components are implemented in line with approved labelling in line with agreed timelines.
+ Participate and contribute to regulatory team meetings and be recognized as a knowledgeable resource for Regulatory Affairs in other departments.
+ May participate and lead collaborative efforts across function in process improvement initiatives.
+ Use internal electronic systems for planning, preparing, tracking and storing submissions to regulatory agencies.
**REQUIREMENTS:**
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
**Education & Experience**
BA/BS or advanced degree in life sciences or related field with regulatory experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Experience a broad range of regulatory activities and setting the regulatory strategy for biopharmaceutical products.
**Knowledge & Other Requirements**
+ A good working regulatory knowledge, including ICH and regional requirements.
+ An appreciation of current global and regional trends in Regulatory Affairs with proven effectiveness in applying this knowledge to optimize team deliverables.
+ Previous experience of working with emerging markets and/or in the Virology therapeutic area would be an advantage but not essential.
+ Methodical attention to detail.
+ Must have a "can do" attitude and be "hands on" as and when required.
+ Proven track record to manage, formulate and execute strategy.
+ Strong interpersonal skills and understanding of team dynamics.
+ Strong communication and organizational skills.
+ Strong negotiation and conflict resolution skills.
**Equal Employment Opportunity (EEO)**
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
This advertiser has chosen not to accept applicants from your region.
9