193 Director Of Regulatory Affairs jobs in the United Kingdom
Associate Director Regulatory Affairs
London, London
Pharma Partners Recruitment Ltd
Posted today
Job Viewed
Job Description
Job title: Associate Director, Regulatory Affairs A Pharmaceutical business in London is looking for an Associate Director, Regulatory Affairs to join their team. In this role you will hold either a EU Regulatory Lead role or Global Regulatory Lead role depending on the portfolio of products assigned. Responsibilities: Working together with multi-functional / geographical teams and other internal stakeholders to ensure that projects meet all key objectives and are delivered on time. Develop Regulatory Strategies for any new submissions as well as identifying risks. Contribute to the preparation of briefing packages for Scientific Advice and orphan drug designations. Participate during the interactions with Health Authorities. Requirements: Substantial experience within Regulatory affairs and pharmaceutical industry. Extensive experience in the submission of new products. Experience working with new MA's. Experience interacting with EU/UK regulatory authorities. Salary and benefits: A highly competitive salary and wider benefits scheme is on offer. To apply for this position or hear further details then please contact Freddie Hill via
This advertiser has chosen not to accept applicants from your region.
0
Associate Director Regulatory Affairs
London, London
Pharma Partners Recruitment Ltd
Posted today
Job Viewed
Job Description
Job title: Associate Director, Regulatory Affairs A Pharmaceutical business in London is looking for an Associate Director, Regulatory Affairs to join their team. In this role you will hold either a EU Regulatory Lead role or Global Regulatory Lead role depending on the portfolio of products assigned. Responsibilities: Working together with multi-functional / geographical teams and other internal stakeholders to ensure that projects meet all key objectives and are delivered on time. Develop Regulatory Strategies for any new submissions as well as identifying risks. Contribute to the preparation of briefing packages for Scientific Advice and orphan drug designations. Participate during the interactions with Health Authorities. Requirements: Substantial experience within Regulatory affairs and pharmaceutical industry. Extensive experience in the submission of new products. Experience working with new MA's. Experience interacting with EU/UK regulatory authorities. Salary and benefits: A highly competitive salary and wider benefits scheme is on offer. To apply for this position or hear further details then please contact Freddie Hill via
This advertiser has chosen not to accept applicants from your region.
1
Global Associate Director, Regulatory Affairs
Hertfordshire, Eastern
Cpl Life Sciences
Posted today
Job Viewed
Job Description
Job Title: Global Associate Director, Regulatory Affairs Job Type: Full-time permanent position Location: Hertfordshire, UK – Hybrid (2/3 days per week in the office) Remuneration: Competitive benefits package An exciting opportunity to join an established pharmaceutical company that specialises in Oncology and Neurology. The role will be working across both portfolios and will have a heavy focus on regulatory strategy. Directing the development of submission of Neurology and Oncology clinical trial applications, product registration dossiers, supplements, and amendments. Provides strategic product direction to project teams on interacting and negotiating with regulatory agencies in order to expedite approval of pending registration and answers any questions. A great opportunity to demonstrate your knowledge in leading regulatory processes for products across the globe, with a focus on oncology and neurology. In this unique position, you will interact with a wide and diverse range of colleagues across the organisation. Responsibilities: Provides strategic product direction to project teams on interacting and negotiating with regulatory agencies in order to expedite approval of pending registration and answers any questions. Regulatory Submissions (CTA/MAA): Participating in regulatory submission activities and reviewing regulatory documents prior to submission to ensure overall quality, compliance and timeliness. Partnering with project teams to assess regulatory support needs and align resources (i.e., sub teams) to provide regulatory support. Creation of regulatory documents, working with the cross functional team to create responses per Agency timelines. Interfacing with Authorities: Acting as the point of contact with regulatory authorities for assigned product(s). Leading calls or meetings with regulatory authorities. Authoring Scientific Advice requests, leading team strategy. Regulatory Strategy Development: Contributing to the development of global regulatory strategies across programs for own functional area and region. Identifying, monitoring and resolving regulatory issues and reporting progress to management Serves as a regulatory liaison on the project team throughout the product lifecycle. Ensures that clinical trial designs meet regulatory requirements. Ensures rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices. Advice on all aspects of product development from a regulatory perspective. Requirements: Bachelor's degree Extensive industry experience with demonstrated experience in direct Regulatory Affairs in the biotech/biopharmaceutical industry. Demonstrated track record of interfacing effectively with global regulatory agencies, such as the EMA. Experience in Clinical Trial Applications, including submission and maintenance Paediatric Investigation Plan experience preferred but not required. Strong understanding and practical experience with regulations and guidelines governing pharmaceutical development and registration. An excellent opportunity to work for a leading pharmaceutical company at the heart of science and neuroscience development. The role comes with some excellent benefits, including a bonus, car allowance life assurance, pension scheme, and private healthcare. This role does not provide sponsorship, and you must have the Right to Work in the UK. For more details about this position, please feel free to contact
This advertiser has chosen not to accept applicants from your region.
2
Global Associate Director, Regulatory Affairs
Hertfordshire, Eastern
Cpl Life Sciences
Posted today
Job Viewed
Job Description
Job Title: Global Associate Director, Regulatory Affairs
Job Type: Full-time permanent position
Location: Hertfordshire, UK – Hybrid (2/3 days per week in the office)
Remuneration: Competitive benefits package
An exciting opportunity to join an established pharmaceutical company that specialises in Oncology and Neurology. The role will be working across both portfolios and will have a heavy focus on regulatory strategy.
Directing the development of submission of Neurology and Oncology clinical trial applications, product registration dossiers, supplements, and amendments. Provides strategic product direction to project teams on interacting and negotiating with regulatory agencies in order to expedite approval of pending registration and answers any questions.
A great opportunity to demonstrate your knowledge in leading regulatory processes for products across the globe, with a focus on oncology and neurology. In this unique position, you will interact with a wide and diverse range of colleagues across the organisation.
Responsibilities:
- Provides strategic product direction to project teams on interacting and negotiating with regulatory agencies in order to expedite approval of pending registration and answers any questions.
- Regulatory Submissions (CTA/MAA): Participating in regulatory submission activities and reviewing regulatory documents prior to submission to ensure overall quality, compliance and timeliness. Partnering with project teams to assess regulatory support needs and align resources (i.e., sub teams) to provide regulatory support. Creation of regulatory documents, working with the cross functional team to create responses per Agency timelines.
- Interfacing with Authorities: Acting as the point of contact with regulatory authorities for assigned product(s). Leading calls or meetings with regulatory authorities. Authoring Scientific Advice requests, leading team strategy.
- Regulatory Strategy Development: Contributing to the development of global regulatory strategies across programs for own functional area and region. Identifying, monitoring and resolving regulatory issues and reporting progress to management
- Serves as a regulatory liaison on the project team throughout the product lifecycle.
- Ensures that clinical trial designs meet regulatory requirements. Ensures rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices.
- Advice on all aspects of product development from a regulatory perspective.
Requirements:
- Bachelor's degree
- Extensive industry experience with demonstrated experience in direct Regulatory Affairs in the biotech/biopharmaceutical industry.
- Demonstrated track record of interfacing effectively with global regulatory agencies, such as the EMA.
- Experience in Clinical Trial Applications, including submission and maintenance
- Paediatric Investigation Plan experience preferred but not required.
- Strong understanding and practical experience with regulations and guidelines governing pharmaceutical development and registration.
An excellent opportunity to work for a leading pharmaceutical company at the heart of science and neuroscience development. The role comes with some excellent benefits, including a bonus, car allowance life assurance, pension scheme, and private healthcare.
This role does not provide sponsorship, and you must have the Right to Work in the UK.
For more details about this position, please feel free to contact
This advertiser has chosen not to accept applicants from your region.
3
Director, Regulatory Affairs, Pre-Market
London, London
GE HealthCare
Posted 21 days ago
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.
4
Associate Director, Regulatory Affairs, Oncology
Cambridge, Eastern
Gilead Sciences, Inc.
Posted 27 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.
5
Associate Director, Regulatory Affairs, Oncology
Uxbridge, London
Gilead Sciences, Inc.
Posted 27 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.
Be The First To Know
About the latest Director of regulatory affairs Jobs in United Kingdom !
6
Global Associate Director, Regulatory Affairs
Hertfordshire, Eastern
Cpl Life Sciences
Posted today
Job Viewed
Job Description
Job Description
Job Title: Global Associate Director, Regulatory Affairs
Job Type: Full-time permanent position
Location: Hertfordshire, UK – Hybrid (2/3 days per week in the office)
Remuneration: Competitive benefits package
An exciting opportunity to join an established pharmaceutical company that specialises in Oncology and Neurology. The role will be working across both portfolios and will have a heavy focus on regulatory strategy.
Directing the development of submission of Neurology and Oncology clinical trial applications, product registration dossiers, supplements, and amendments. Provides strategic product direction to project teams on interacting and negotiating with regulatory agencies in order to expedite approval of pending registration and answers any questions.
A great opportunity to demonstrate your knowledge in leading regulatory processes for products across the globe, with a focus on oncology and neurology. In this unique position, you will interact with a wide and diverse range of colleagues across the organisation.
Responsibilities:
- Provides strategic product direction to project teams on interacting and negotiating with regulatory agencies in order to expedite approval of pending registration and answers any questions.
- Regulatory Submissions (CTA/MAA): Participating in regulatory submission activities and reviewing regulatory documents prior to submission to ensure overall quality, compliance and timeliness. Partnering with project teams to assess regulatory support needs and align resources (i.e., sub teams) to provide regulatory support. Creation of regulatory documents, working with the cross functional team to create responses per Agency timelines.
- Interfacing with Authorities: Acting as the point of contact with regulatory authorities for assigned product(s). Leading calls or meetings with regulatory authorities. Authoring Scientific Advice requests, leading team strategy.
- Regulatory Strategy Development: Contributing to the development of global regulatory strategies across programs for own functional area and region. Identifying, monitoring and resolving regulatory issues and reporting progress to management
- Serves as a regulatory liaison on the project team throughout the product lifecycle.
- Ensures that clinical trial designs meet regulatory requirements. Ensures rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices.
- Advice on all aspects of product development from a regulatory perspective.
Requirements:
- Bachelor's degree
- Extensive industry experience with demonstrated experience in direct Regulatory Affairs in the biotech/biopharmaceutical industry.
- Demonstrated track record of interfacing effectively with global regulatory agencies, such as the EMA.
- Experience in Clinical Trial Applications, including submission and maintenance
- Paediatric Investigation Plan experience preferred but not required.
- Strong understanding and practical experience with regulations and guidelines governing pharmaceutical development and registration.
An excellent opportunity to work for a leading pharmaceutical company at the heart of science and neuroscience development. The role comes with some excellent benefits, including a bonus, car allowance life assurance, pension scheme, and private healthcare.
This role does not provide sponsorship, and you must have the Right to Work in the UK.
For more details about this position, please feel free to contact
This advertiser has chosen not to accept applicants from your region.
7
Director of Regulatory Affairs
Marlow, South East
Pharma Partners Recruitment Ltd
Posted today
Job Viewed
Job Description
Job Title: International Regulatory Affairs Advertising and Promotion Area Lead An exciting opportunity has arisen for a dynamic and driven regulatory professional to join in this leadership role. This high-impact position will ensure that all promotional and non-promotional materials are accurate, balanced, and compliant with applicable industry codes, internal policies, and local regulations. As Area Lead, you will provide expert guidance on promotional compliance and act as a strategic partner across functions, contributing to key business decisions and driving operational excellence in a matrixed, fast-paced environment. Key Responsibilities: Leading a UK-based team (with potential to support additional affiliate teams) focused on the review of promotional and non-promotional materials. Helping ensure materials meet local regulatory requirements and industry Codes of Practice, while still supporting creative and commercially relevant messaging. Working closely with international colleagues to align campaigns and review processes between global and local teams. Offering practical guidance and regulatory insight to colleagues across different teams, including Commercial, Medical, Legal, and Compliance. Staying up to date with relevant regulatory changes and helping teams understand their impact. Bringing a thoughtful, balanced approach to problem-solving, supporting both compliance and business needs. Supporting ongoing process improvements and contributing to broader regulatory and business strategies. Creating a positive, inclusive team environment that supports development and growth. Qualifications & Experience: A Life sciences degree UK-registered Medical Signatory status Experience working in the pharmaceutical industry Some leadership or team management experience, with a supportive and coaching-led approach Confidence working across different teams or departments, especially in complex or matrixed organisations Comfortable supporting a wide range of products, including those at various lifecycle stages Clear and confident communication skills – both written and verbal A collaborative mindset and the ability to guide others through complex decisions Salary and benefits: A highly competitive salary, car allowance, annual bonus, private healthcare and wider benefits are on offer To apply for this position or hear further details then please click “Apply” or reach out via email –
This advertiser has chosen not to accept applicants from your region.
8
Director of Regulatory Affairs
Marlow, South East
Pharma Partners Recruitment Ltd
Posted today
Job Viewed
Job Description
Job Title: International Regulatory Affairs Advertising and Promotion Area Lead
An exciting opportunity has arisen for a dynamic and driven regulatory professional to join in this leadership role. This high-impact position will ensure that all promotional and non-promotional materials are accurate, balanced, and compliant with applicable industry codes, internal policies, and local regulations.
As Area Lead, you will provide expert guidance on promotional compliance and act as a strategic partner across functions, contributing to key business decisions and driving operational excellence in a matrixed, fast-paced environment.
Key Responsibilities:
- Leading a UK-based team (with potential to support additional affiliate teams) focused on the review of promotional and non-promotional materials.
- Helping ensure materials meet local regulatory requirements and industry Codes of Practice, while still supporting creative and commercially relevant messaging.
- Working closely with international colleagues to align campaigns and review processes between global and local teams.
- Offering practical guidance and regulatory insight to colleagues across different teams, including Commercial, Medical, Legal, and Compliance.
- Staying up to date with relevant regulatory changes and helping teams understand their impact.
- Bringing a thoughtful, balanced approach to problem-solving, supporting both compliance and business needs.
- Supporting ongoing process improvements and contributing to broader regulatory and business strategies.
- Creating a positive, inclusive team environment that supports development and growth.
Qualifications & Experience:
- A Life sciences degree
- UK-registered Medical Signatory status
- Experience working in the pharmaceutical industry
- Some leadership or team management experience, with a supportive and coaching-led approach
- Confidence working across different teams or departments, especially in complex or matrixed organisations
- Comfortable supporting a wide range of products, including those at various lifecycle stages
- Clear and confident communication skills – both written and verbal
- A collaborative mindset and the ability to guide others through complex decisions
Salary and benefits:
A highly competitive salary, car allowance, annual bonus, private healthcare and wider benefits are on offer
To apply for this position or hear further details then please click “Apply” or reach out via email –
This advertiser has chosen not to accept applicants from your region.
9