Regulatory Affairs Director
3 weeks ago
At Cpl Life Sciences, we are seeking an experienced Regulatory Affairs Director to lead our global regulatory strategies. This role will be responsible for providing strategic regulatory advice to clients, taking into account regulatory guidelines and available measures to facilitate regulatory input, incentives, and early market access.
Key Responsibilities:
- Lead client projects, providing regulatory advice on filing routes, timings, and regulatory authority interactions.
- Preparation of regulatory submission documents, including orphan drug designation applications and marketing authorisation applications.
- Lead regulatory agency interactions/negotiations to ensure client goals are met.
- Complete Senior Quality Control (QC) review as required.
- Lead on complex, multifactorial regulatory projects requiring input from several functions.
Qualifications
- B.Sc. in a life sciences subject and/or a higher degree.
- At least 10 years of industry experience in a regulatory role.
- Prior experience in a CRO/pharmaceutical environment.
- Extensive experience driving global regulatory strategies.
-
Regulatory Affairs Director
1 month ago
Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time £85,000 - £110,000Associate Director, Regulatory AffairsCpl Life Sciences is seeking an experienced Associate Director, Regulatory Affairs to join our team. This is a permanent, full-time opportunity based in Cambridge, UK, with a hybrid/remote work arrangement.About the RoleWe are looking for a highly skilled and motivated individual to lead our regulatory affairs strategy...
-
Regulatory Affairs Director
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time £85,000 - £110,000**Regulatory Affairs Director Role Overview**Cpl Life Sciences is seeking a highly experienced Regulatory Affairs Director to lead our global regulatory strategy and drive business growth.As a key member of our team, you will be responsible for developing and implementing regulatory strategies to ensure compliance with global regulations and guidelines.**Key...
-
Regulatory Affairs Director
1 month ago
Cambridge, Cambridgeshire, United Kingdom CTI Clinical Trial and Consulting Services Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at CTI Clinical Trial and Consulting Services. As an Associate Director, Regulatory Affairs, you will play a critical role in developing and delivering innovative global regulatory strategies for our sonelokimab lead indication(s).Key Responsibilities:Develop and...
-
Regulatory Affairs Director
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeAbout the RoleMoonLake Immunotherapeutics is seeking a highly skilled Regulatory Affairs Director to join our dynamic team.This is an exciting opportunity to develop and deliver innovative global regulatory strategies for sonelokimab lead indication(s).As a key member of our team, you will be responsible for regulatory aspects related to product development...
-
Regulatory Affairs Director
1 month ago
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeJob Overview At MoonLake Immunotherapeutics, we are seeking an experienced Associate Director of Regulatory Affairs to join our team. As a key member of our regulatory affairs team, you will play a critical role in developing and delivering innovative global regulatory strategies for our sonelokimab lead indication(s). Responsibilities * Collaborate with...
-
Regulatory Affairs Director
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full timeJob Title: Associate Director, Regulatory AffairsJob Type: Permanent, full-timeLocations: Cambridge, UK – Hybrid/RemoteRemuneration: £85,000 - £110,000 + benefitsCpl Life Sciences is seeking a highly skilled Regulatory Affairs professional to lead strategy for development programs globally, support all areas of development, and support any area of...
-
Regulatory Affairs Director
1 month ago
Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd Full timeRegulatory Affairs DirectorProTech Recruitment Ltd is seeking a highly skilled Regulatory Affairs Director to lead the regulatory strategy for innovative medical products. This individual will ensure compliance with global quality standards and navigate complex regulatory landscapes to bring cutting-edge technologies to market.The ideal candidate will have...
-
Regulatory Affairs Director
1 month ago
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeJob OverviewMoonLake Immunotherapeutics is seeking an experienced Associate Director, Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for developing and delivering innovative global regulatory strategies for sonelokimab lead indication(s).You will work closely with functional colleagues and...
-
Regulatory Affairs Director
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full timeJob SummaryWe are seeking an experienced Associate Director, Regulatory Affairs CMC to join our team at Bicycle Therapeutics. The successful candidate will be responsible for developing and executing global regulatory CMC strategy and submissions for assigned programs or projects.Key ResponsibilitiesDevelop and execute global regulatory CMC strategy and...
-
Regulatory Affairs Director
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Lifelancer Full timeJob DescriptionCompany Overview: Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT.We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains. Our mission is to provide innovative solutions for businesses and professionals in the industry.SalaryThe estimated salary for this position...
-
Regulatory Affairs Director
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeJob OverviewMoonLake Immunotherapeutics is seeking an experienced Associate Director to lead the development and implementation of innovative global regulatory strategies for sonelokimab lead indication(s).This role will be responsible for regulatory aspects related to product development and approval, in alignment with the global business strategy and in...
-
Global Regulatory Affairs Labeling Director
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeJob Title: Global Regulatory Affairs Labeling DirectorJob Summary:Gilead Sciences International, Ltd. is seeking a highly experienced Global Regulatory Affairs Labeling Director to lead our Global Regulatory Affairs Labeling organization. The successful candidate will be responsible for developing and implementing global labeling strategies, ensuring...
-
Global Regulatory Affairs Director
4 days ago
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeJob OverviewMoonLake Immunotherapeutics seeks a highly skilled Global Regulatory Affairs Director to lead the development and implementation of innovative global regulatory strategies for sonelokimab lead indication(s).This role will be responsible for regulatory aspects related to product development and approval, aligning with the global business strategy...
-
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeAbout the RoleGilead Sciences International, Ltd. is seeking a highly skilled Regulatory Affairs Director for Precision Medicine to join our team. As a key member of our regulatory affairs team, you will be responsible for developing and executing precision medicine regulatory strategies in alignment with our global regulatory strategy.Key...
-
Regulatory Affairs Director
1 month ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeAbout the RoleWe are seeking an experienced Regulatory Affairs professional to join our global team at Gilead Sciences International, Ltd.Key ResponsibilitiesDevelop and implement regulatory strategies for assigned products or projects.Collaborate with cross-functional teams to shape dossier content for global rollout and life cycle management.Oversee the...
-
Senior Regulatory Affairs Labeling Director
3 days ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeJob Title: Senior Regulatory Affairs Labeling DirectorGilead Sciences International, Ltd. is seeking a highly experienced Senior Regulatory Affairs Labeling Director to lead the Global Regulatory Labeling team.Key Responsibilities:Develop and implement global labeling strategies to ensure compliance with evolving regulatory requirements.Lead a team of...
-
Regulatory Affairs Director
4 days ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeAbout the Role:Gilead Sciences International, Ltd. seeks an experienced Regulatory Affairs Director to lead our biologics efforts in a dynamic global team environment.Job Summary:This key leadership position requires a seasoned professional with expertise in CMC regulatory affairs and strong leadership presence to oversee EU Regulatory submissions and drive...
-
Regulatory Affairs Program Director
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom ProductLife Group Full timeRegulatory Affairs Program Director - European Pharmaceutical ExpertProductLife Group is seeking a highly skilled Regulatory Affairs Program Director to lead our outsourcing projects in the European pharmaceutical industry. As a key member of our team, you will be responsible for managing Regulatory Affairs outsourcing projects for major clients, ensuring...
-
Senior Regulatory Affairs Labeling Director
1 month ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeJob SummaryWe are seeking a highly experienced and skilled Senior Regulatory Affairs Labeling Director to lead our Global Regulatory Affairs Labeling team at Gilead Sciences International, Ltd. This is a critical role that requires a strong understanding of global labeling regulatory requirements and strategy, as well as excellent leadership and...
-
Regulatory Affairs Program Director
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom ProductLife Group Full timeRegulatory Affairs Program Director - European Pharmaceutical ExpertProductLife Group is seeking a seasoned Regulatory Affairs Program Director to lead our European pharmaceutical projects. As a key member of our team, you will be responsible for managing outsourcing programs for major clients, ensuring the delivery of high-quality Regulatory Affairs...