Regulatory Affairs Expert
2 weeks ago
Job Type: Permanent, full-time position
Berkshire, UK – 3 days on-site per week
Attractive salary and package
We are partnered with a leading Pharmaceutical organisation who are looking for an experienced Associate Director, Regulatory Affairs to join their Neuroscience division. This role will be leading European strategy for a developing and marketed Neurology portfolio.
Key Responsibilities:
- Implement regulatory strategies for early/late development and marketed products in Neuroscience for Europe and non-EU CEE countries, Israel, Turkey, Switzerland and the UK) in alignment with the overarching global regulatory strategy and region-specific requirements.
- Support clinical trials under EU CTR, scientific advice, and PIPS.
- Provide strategic input for registration, ensure the business needs are met by anticipating and mitigating regulatory risks while ensuring compliance with regulations, assess probability of success for submission, approval, and launch.
- Receives delegation to manage EMA meetings and other agency key meetings in liaison with affiliate regulatory managers.
- Responsible for planning and ultimately leading MAA-related processes and strategy to ensure timely product approvals with competitively differentiated labelling.
- Monitor emerging legislation and guidance in the EU and contribute to ensuring company-level awareness and compliance (where appropriate).
Requirements:
- Sound knowledge of both pharmaceutical regulations and guidelines and national regulations within the assigned region.
- Extensive demonstrated prior relevant experience in pharmaceutical Regulatory Affairs and regulatory procedures (including CP/DCP/MRP).
- At least 8/10 years of experience in a Regulatory Affairs role within the pharma/Biotech/CRO industry.
- Experience in dealings with the EMA (scientific advice, orphan designation, PIPs).
- Experience in providing EU regulatory strategy.
- You will take the lead and work with senior board members across the globe to define regulatory / business strategy.
Please note you MUST be based in the UK to apply for this role and be able to commute to Berkshire 2/3 days per week.
-
Regulatory Affairs Director
4 weeks ago
Windsor, Windsor and Maidenhead, United Kingdom Cpl Life Sciences Full timeCpl Life Sciences is seeking an experienced Associate Director, Regulatory Affairs to join their Neuroscience division. This role will lead European strategy for a developing and marketed Neurology portfolio. As an Associate Director, Regulatory Affairs, you will have excellent experience with both developing and marketed products and be confident with...
-
Regulatory Affairs Director
4 weeks ago
Windsor, Windsor and Maidenhead, United Kingdom Cpl Life Sciences Full timeCpl Life Sciences is seeking an experienced Associate Director, Regulatory Affairs to join their Neuroscience division. This role will lead European strategy for a developing and marketed Neurology portfolio. As an Associate Director, Regulatory Affairs, you will have excellent experience with both developing and marketed products and be confident with...
-
Regulatory Affairs Director
4 weeks ago
Windsor, Windsor and Maidenhead, United Kingdom Cpl Life Sciences Full timeRegulatory Affairs Director Job DescriptionCpl Life Sciences is seeking an experienced Regulatory Affairs Director to join their Neuroscience division. As a key member of the team, you will be responsible for leading European strategy for a developing and marketed Neurology portfolio.Key Responsibilities:Implement regulatory strategies for early/late...
-
Regulatory Affairs Director
4 weeks ago
Windsor, Windsor and Maidenhead, United Kingdom Cpl Life Sciences Full timeRegulatory Affairs Director Job DescriptionCpl Life Sciences is seeking an experienced Regulatory Affairs Director to join their Neuroscience division. As a key member of the team, you will be responsible for leading European strategy for a developing and marketed Neurology portfolio.Key Responsibilities:Implement regulatory strategies for early/late...
-
Regulatory Affairs Director
3 weeks ago
Windsor, Windsor and Maidenhead, United Kingdom Cpl Life Sciences Full timeJob Title: Associate Director, Regulatory AffairsJob Type: Permanent, full-time positionLocation: Berkshire, UK – 3 days on-site per weekRemuneration: Attractive salary and packageWe are seeking an experienced Associate Director, Regulatory Affairs to join our Neuroscience division. This role will involve leading European strategy for a developing and...
-
Regulatory Affairs Director
2 weeks ago
Windsor, Windsor and Maidenhead, United Kingdom Cpl Life Sciences Full timeJob Title: Associate Director Regulatory AffairsJob Type: Permanent, full-time positionLocation: Berkshire, UK – 3 days on-site per weekRemuneration: Attractive salary and packageCpl Life Sciences is partnering with a leading Pharmaceutical organisation to find an experienced Associate Director, Regulatory Affairs to join their Neuroscience division. This...
-
Regulatory Affairs Director
2 weeks ago
Windsor, Windsor and Maidenhead, United Kingdom Cpl Life Sciences Full timeJob Title: Associate Director Regulatory AffairsJob Type: Permanent, full-time positionLocation: Berkshire, UK – 3 days on-site per weekRemuneration: Attractive salary and packageCpl Life Sciences is partnering with a leading Pharmaceutical organisation to find an experienced Associate Director, Regulatory Affairs to join their Neuroscience division. This...
-
Regulatory Affairs Director
3 weeks ago
Windsor, Windsor and Maidenhead, United Kingdom Cpl Life Sciences Full timeJob Title: Associate Director, Regulatory AffairsJob Type: Permanent, full-time positionLocation: Berkshire, UK – 3 days on-site per weekRemuneration: Attractive salary and packageWe are seeking an experienced Associate Director, Regulatory Affairs to join our Neuroscience division. This role will involve leading European strategy for a developing and...
-
Regulatory Affairs Director
2 weeks ago
Windsor, Windsor and Maidenhead, United Kingdom Cpl Life Sciences Full timeJob Title: Associate Director Regulatory AffairsJob Type: Permanent, full-time positionLocation: Berkshire, UK – 3 days on-site per weekRemuneration: Attractive salary and packageWe are seeking an experienced Associate Director, Regulatory Affairs to join our Neuroscience division. This role will lead European strategy for a developing and marketed...
-
Regulatory Affairs Director
3 weeks ago
Windsor, Windsor and Maidenhead, United Kingdom Cpl Life Sciences Full timeJob Title: Associate Director, Regulatory AffairsJob Summary:We are seeking an experienced Associate Director, Regulatory Affairs to join our Neuroscience division. The successful candidate will lead European strategy for a developing and marketed Neurology portfolio.Key Responsibilities:Develop and implement regulatory strategies for early/late development...
-
Regulatory Affairs Director
3 weeks ago
Windsor, Windsor and Maidenhead, United Kingdom Cpl Life Sciences Full timeJob Title: Associate Director, Regulatory AffairsJob Summary:We are seeking an experienced Associate Director, Regulatory Affairs to join our Neuroscience division. The successful candidate will lead European strategy for a developing and marketed Neurology portfolio.Key Responsibilities:Develop and implement regulatory strategies for early/late development...
-
Regulatory Affairs Specialist
1 week ago
Windsor, Windsor and Maidenhead, United Kingdom Centrica Full timeWe are Centrica, a family of brands revolutionising a cleaner, greener future. Our purpose is to energise a greener, fairer future, and we're looking for a Regulatory Affairs Specialist to join our team.The Regulatory Affairs function understands, provides advice on and influences the various regulatory components of the energy sector, ensuring Centrica...
-
Regulatory Affairs Specialist
2 months ago
Windsor, Windsor and Maidenhead, United Kingdom Centrica Full timeAbout the RoleWe are seeking a highly skilled Regulatory Manager to join our team at Centrica. As a key member of our Regulatory Affairs function, you will play a critical role in understanding, advising on, and influencing the various regulatory components of the energy sector.Key responsibilities will include managing and influencing arrangements and...
-
Regulatory Affairs Specialist
2 months ago
Windsor, Windsor and Maidenhead, United Kingdom Centrica Full timeAbout the RoleWe are seeking a highly skilled Regulatory Manager to join our team at Centrica. As a key member of our Regulatory Affairs function, you will play a critical role in understanding, advising on, and influencing the various regulatory components of the energy sector.Key responsibilities will include managing and influencing arrangements and...
-
Regulatory Affairs Specialist
3 weeks ago
Windsor, Windsor and Maidenhead, United Kingdom Centrica Full timeAbout the RoleWe are seeking a highly skilled Regulatory Manager to join our team at Centrica. As a key member of our Regulatory Affairs function, you will play a vital role in understanding, advising on, and influencing the various regulatory components of the energy sector.Key responsibilities will include:Managing our engagement with the Balancing and...
-
Regulatory Affairs Specialist
3 weeks ago
Windsor, Windsor and Maidenhead, United Kingdom Centrica Full timeAbout the RoleWe are seeking a highly skilled Regulatory Manager to join our team at Centrica. As a key member of our Regulatory Affairs function, you will play a vital role in understanding, advising on, and influencing the various regulatory components of the energy sector.Key responsibilities will include:Managing our engagement with the Balancing and...
-
Regulatory Affairs Specialist
1 month ago
Windsor, Windsor and Maidenhead, United Kingdom Centrica Full timeAbout the RoleWe are seeking a highly skilled Regulatory Manager to join our team at Centrica. As a key member of our Regulatory Affairs function, you will play a vital role in understanding, advising on, and influencing the various regulatory components of the energy sector.Key responsibilities will include:Managing our engagement with the Balancing and...
-
Regulatory Affairs Specialist
1 month ago
Windsor, Windsor and Maidenhead, United Kingdom Centrica Full timeAbout the RoleWe are seeking a highly skilled Regulatory Manager to join our team at Centrica. As a key member of our Regulatory Affairs function, you will play a vital role in understanding, advising on, and influencing the various regulatory components of the energy sector.Key responsibilities will include:Managing our engagement with the Balancing and...
-
Regulatory Affairs Specialist
2 weeks ago
Windsor, Windsor and Maidenhead, United Kingdom Centrica Full timeWe are Centrica, a family of brands revolutionising a cleaner, greener future. Our purpose is to energise a greener, fairer future, and we're looking for a Regulatory Affairs Specialist to join our team.This role will involve managing and influencing arrangements and accountabilities for service provision and performance management through the Balancing and...
-
Compliance Specialist
1 week ago
Windsor, Windsor and Maidenhead, United Kingdom InterSystems Full timeJob SummaryWe are seeking a highly skilled Compliance Specialist to join our team at InterSystems. As a key member of our Risk & Compliance service, you will play a critical role in helping departments across the company develop and implement processes to ensure our software solutions comply with regulatory requirements, standards, and guidelines related to...
