174 Regulatory Affairs Associate jobs in the United Kingdom
Regulatory Affairs Associate - Cosmetics
Posted 4 days ago
Job Viewed
Job Description
Join a Science-Led Consumer Healthcare Pioneer on an Exciting Growth Journey
Are you ready to be part of something extraordinary? At Alliance, we're a dynamic, science-led consumer healthcare organisation specialising in advanced skincare solutions and vitamins, minerals & supplements (VMS). Backed by innovation and driven by purpose, we're on an exciting journey of transformation and growth — expanding our reach, enhancing our brands, and bringing cutting-edge products to more consumers across the globe.
As a Regulatory Scientist - Cosmetics, you’ll act as a subject matter expert in cosmetic regulations, partnering closely with cross-functional teams to ensure compliance while empowering creativity. You’ll play a pivotal role in bringing safe, compliant, and inspiring products to market — all while helping shape the future of regulatory practice within the cosmetics industry.
What You’ll Be Doing
- Supporting the implementation of robust regulatory strategies to ensure compliance and commercial success.
- Providing regulatory expertise to innovation projects, enabling smooth and timely product launches.
- Creating, maintaining, and approving regulatory documentation, including submissions to databases.
- Maintaining the EMEA cosmetics portfolio and supporting medical device compliance.
- Leading departmental Quality Management System (QMS) activities and supporting audits, SOPs, and CAPAs.
- Representing regulatory affairs in cross-functional meetings, offering clear advisory input.
- Contributing to industry consultations, forums, and discussions to influence regulatory best practices.
- Driving continuous professional development for yourself and supporting knowledge growth within the team.
What we’re looking for
We’re seeking someone who brings both technical expertise and a collaborative mindset. You’ll have:
- A degree (BSc/MSc) in Life Sciences, Cosmetics, Pharmacy, Chemistry or related discipline.
- Solid knowledge of UK/EU cosmetic regulations (with global exposure desirable).
- Familiarity with medical device regulations (EU Cosmetics Regulation, MDR, ISO standards).
- Experience preparing, reviewing, and submitting regulatory dossiers, notifications, and documentation.
- Working knowledge of QMS processes (SOPs, audits, CAPAs).
- Strong ability to interpret regulations, advise teams, and support compliance strategies.
- Proven track record of supporting new product launches through effective regulatory input.
- Excellent regulatory writing, documentation management, and database submission skills.
Why join us
This is more than a regulatory role — it’s an opportunity to be part of an organisation where science meets creativity. You’ll work alongside talented teams who are passionate about delivering products that consumers trust, value, and love.
If you’re driven by innovation, enjoy influencing change, and thrive in a collaborative environment, we’d love to hear from you.
What we offer
- Competitive salary with discretionary bonus
- 25 days holiday + 1 celebration day + 1 volunteering day + bank holidays, with the option to buy up to 10 extra days
- Generous pension scheme (up to 10% employer contribution)
- Life assurance (4x salary)
- Private medical cover and health cash plan (with options for family cover)
- Wellbeing support: eye care, flu vaccine, EAP & discounts via Perks at Work
- Salary sacrifices options with the Cycle scheme and electric vehicle schemes
- Flexible working and family-friendly policies
- Global recognition programme & £1,000 referral bonus
If you are looking to make a difference and be part of something exciting, we’d love to hear from you
Senior Regulatory Affairs Associate CMC (plasma products)
Posted 11 days ago
Job Viewed
Job Description
As a **Senior Regulatory Affairs Associate CMC** at Parexel, you will be at the forefront of managing and coordinating regulatory submissions across various markets. This role offers an excellent opportunity to develop your expertise in regulatory affairs while working with a diverse range of clients and stakeholders.
The role can be home or office based in various European locations.
**Role Responsibilities:**
- Manage lifecycle maintenance activities, including renewals, variations, and responses to deficiency letters
- Coordinate submission and management work in Veeva Vault
- Collaborate with various stakeholders, attending regular calls and meetings
- May serve as Project Lead for small-scale projects or Work Stream Lead on larger projects
- Ensure project team delivers high-quality work meeting client expectations and timelines
- Manage project financials and identify new business opportunities
- Deliver consulting services within your area of expertise
- Maintain professional interactions with clients and internal teams
**Skills and experience required for the role:**
- University degree in a life science discipline
- Initial years of regulatory experience in EU and other non-EU markets preferred
- Proficiency in Module 1 and 3 writing for plasma products
- Strong organizational and prioritization skills
- Excellent communication and teamwork abilities
- Ability to work independently and under guidance of Project Leads or Technical SMEs
- Commitment to continuous learning and self-development
- Fluent in English, written and spoken.
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Associate Director Regulatory Affairs
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
Associate Director Regulatory Affairs
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
Associate Director Regulatory Affairs
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 -partners.co.uk
Associate Director Regulatory Affairs
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 -partners.co.uk
Global Associate Director, Regulatory Affairs
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
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Associate Director, Regulatory Affairs, Oncology
Posted 28 days ago
Job Viewed
Job Description
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.
Associate Director, Regulatory Affairs, Oncology
Posted 28 days ago
Job Viewed
Job Description
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.
Global Associate Director, Regulatory Affairs
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