Current jobs related to Regulatory Affairs Program Director - Cambridge, Cambridgeshire - ProductLife Group
-
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...
-
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 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
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...
-
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
3 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...
-
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...
-
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...
-
Global Regulatory Affairs Director
5 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...
-
Regulatory Affairs Director
5 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...
-
Senior Regulatory Affairs Director
1 day ago
Cambridge, Cambridgeshire, United Kingdom Lifelancer Full timeRegulatory Affairs Director Job OverviewWe are seeking a highly skilled Regulatory Affairs Director to join our team at Lifelancer. As a key member of our organization, you will be responsible for developing and delivering innovative global regulatory strategies for sonelokimab lead indication(s).About the RoleThis is an exciting opportunity to work with a...
-
Regulatory Affairs Director
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full timeJob DescriptionAt 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...
-
Regulatory Affairs Director, Precision Medicine
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeAbout the Role:Gilead Sciences International, Ltd. is seeking a highly skilled Regulatory Affairs Director, Precision Medicine to join our team.Responsibilities:Develop and Execute Regulatory Strategies: Collaborate with cross-functional stakeholders to develop and execute precision medicine regulatory strategies in alignment with the company's global...
-
Regulatory Affairs Specialist
4 days ago
Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full timeJob OverviewWe are seeking a highly skilled Senior Associate, Regulatory Affairs to join our team at Bicycle Therapeutics. As a key member of our regulatory affairs department, you will be responsible for the development, execution, and tracking of global regulatory submissions for assigned programs or projects.
-
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Director to join our team at Gilead Sciences International, Ltd. as a Director, Global Regulatory Affairs, Precision Medicine. This is a unique opportunity to develop and execute Precision Medicine regulatory strategies in alignment with the drug global regulatory strategy in collaboration with...
-
Senior Regulatory Affairs Labeling Director
4 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...
-
Cambridge, Cambridgeshire, United Kingdom Lifelancer Full timeAbout LifelancerLifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talented professionals with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.Job Title: Global Clinical Program Manager for Biotech Regulatory AffairsWe are seeking a highly skilled Global Clinical Program Manager for our...
-
Associate Director, Regulatory Affairs CMC
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full timeJob DescriptionThe Associate Director, Regulatory Affairs CMC will be responsible for the development, strategy, execution, and tracking of CMC regulatory activities for assigned BicycleTx programs or projects.Key ResponsibilitiesCMC Regulatory Strategy and Submissions: Develop and execute global regulatory CMC strategy and submissions for assigned BicycleTx...
-
Regulatory Affairs Manager
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full timeCompany OverviewBicycle Therapeutics is a cutting-edge company that focuses on revolutionizing the field of pharmaceuticals through innovative technologies and groundbreaking research.We are committed to building a diverse workforce that reflects the communities we serve, fostering an inclusive environment where everyone can thrive.SalaryThe estimated salary...
-
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeGilead Sciences International, Ltd. is seeking an experienced Regulatory Affairs Director to oversee regulatory activities in the Gilead Patient Solutions region.About the RoleThis exciting opportunity allows you to leverage your expertise in regulatory affairs to provide strategic guidance and oversight to in-market partners.Key ResponsibilitiesDevelop and...
Regulatory Affairs Program Director
4 weeks ago
Regulatory Affairs Program Director - European Pharmaceutical Expert
ProductLife 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 services within agreed timelines.
About the Role
You will act as a direct point of contact with clients, coordinating outsourcing projects for their Regulatory Affairs activities in Europe. Your key tasks will include:
- Project management of programs, ensuring workload management, resource allocation, performance review, and cost management.
- Line management of employees onboarded for programs, including training, individual development plans, salary reviews, and support.
- Communication with clients and internal stakeholders to ensure seamless information exchange.
- Guaranteeing the delivery of high-quality RA services to clients within agreed timelines.
Requirements
To succeed in this role, you will need:
- 8+ years of experience in European Regulatory Affairs.
- Knowledge of EU RA regulations for pharmaceuticals, including NCEs, Biologicals, and Biotech.
- Experience in line management, resource management, and invoice management.
- Fluent English and excellent communication skills.
- Top-notch organizational skills, proven leadership skills, and business acumen.
- Ability to work proactively and as part of a team.
About Us
ProductLife Group is a leading company in the pharmaceutical industry, dedicated to delivering high-quality Regulatory Affairs services to our clients. We are committed to excellence and innovation, and we are seeking a talented individual to join our team.
