Regulatory Affairs Director
15 hours ago
Job Title: Regulatory Affairs Director
We are seeking a highly skilled and experienced Regulatory Affairs Director 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.
The ideal candidate will have extensive experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry, with a strong understanding of FDA, EMA, ICH, and cGMP CMC regulatory guidance and regulations. A bachelor's degree in a scientific field or post-graduate degree is preferred.
A competitive salary of $120,000 per annum is on offer, plus benefits including annual company bonus, employee recognition schemes, 28 days annual leave, employer contribution to pension, life assurance cover, private medical insurance, and more.
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Regulatory Affairs Director
12 hours ago
Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full timeOverviewCpl Life Sciences is seeking a Senior Director Regulatory Affairs to join our team. This role offers the opportunity to lead client projects, provide strategic regulatory advice, and ensure compliance with UK, EU, and US health authorities.About the RoleAs Senior Director Regulatory Affairs, you will be responsible for preparing regulatory submission...
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Regulatory Affairs Director
14 hours ago
Cambridge, Cambridgeshire, United Kingdom Indo Search Full timeRegulatory Affairs Director - MedTechWe are seeking a highly experienced Regulatory Affairs Director to join our team in Cambridge, UK. As a key member of our organization, you will be responsible for developing and implementing global regulatory strategies for advanced Class IIb/III medical devices.Key Responsibilities:Develop and implement global...
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Senior Regulatory Affairs Director
3 weeks 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...
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Compliance and Regulatory Affairs Director
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Vertex Ventures HC Full timeJob Title: Compliance and Regulatory Affairs DirectorAbout Bicycle Therapeutics:We are a clinical-stage biopharmaceutical company dedicated to developing innovative medicines for underserved diseases. Our team is passionate about improving the lives of patients and driving meaningful change in the industry.Job Summary:The Compliance and Regulatory Affairs...
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Regulatory Affairs Director
1 month 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...
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Global Regulatory Affairs Director
4 weeks 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...
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Senior Regulatory Affairs Labeling Director
4 weeks 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...
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Regulatory Affairs Director
4 weeks 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...
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Regulatory Affairs Expert
3 days ago
Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full timeJob OverviewWe are seeking a highly experienced Senior Director to lead our Regulatory Affairs team at Cpl Life Sciences. This role will provide strategic regulatory advice to clients, taking into account regulatory guidelines and available measures to facilitate regulatory input.Key Responsibilities:Lead client projects, providing expert regulatory guidance...
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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...
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Regulatory Affairs Director, Precision Medicine
1 month 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...
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Senior Director Regulatory Guidance
3 days ago
Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full timeAbout the Role:We are looking for an accomplished Senior Director to join our team as a Regulatory Affairs Leader. You will oversee the Regulatory Affairs team, providing strategic regulatory advice to clients and driving global Regulatory Affairs Strategies.Responsibilities:Lead client projects, offering expert regulatory guidance.Prepare and review...
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Regulatory Affairs Expert
3 days ago
Cambridge, Cambridgeshire, United Kingdom Thor Companies Full timeRegulatory Affairs Expert WantedWe are seeking a Regulatory Affairs Expert to join our team in Cambridge, UK. The successful candidate will have a strong background in pharma/biopharma and be able to work independently.About the Role:The ideal candidate will have at least 10 years' experience in regulatory affairs.Proven ability to manage projects and...
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Regulatory Affairs Specialist
4 weeks 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.
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Regulatory Affairs Specialist
3 days ago
Cambridge, Cambridgeshire, United Kingdom Voisin Consulting SARL Full timeAbout VCLSWe are a leading consulting firm offering expert regulatory services to the pharmaceutical and medical device sectors. Our team is dedicated to providing high-quality support to our clients, ensuring compliance with regulatory requirements.This 30-month programme is designed for recent graduates with an interest in medicines and a desire to build a...
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Cambridge, Cambridgeshire, United Kingdom Vertex Ventures HC Full timeCompany Overview:Bicycle Therapeutics is a dynamic pharmaceutical company committed to delivering innovative treatments for challenging diseases. Our team is driven by a passion for innovation and a commitment to excellence.Salary:$220,000 - $270,000 per yearJob Description:We are seeking a seasoned Regulatory Affairs Director with Strategic Expertise to...
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Regulatory Affairs Specialist
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Vectura Group Full timeJob SummaryWe are seeking a skilled Regulatory Affairs Specialist to join our team at Vectura Group. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with global regulations and guidelines for medical devices and drug-device combination products.Key Responsibilities:Lead regulatory activities across...
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Regulatory Affairs Specialist
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom VCLS Full timeVCLS is seeking a highly skilled Regulatory Affairs Specialist to drive forward regulatory processes, ensure compliance, and contribute to innovative clinical trials. The ideal candidate will have 4+ years of experience in Regulatory Affairs, with a focus on Clinical Trial Submissions (CTS). They will possess a deep understanding of regional and local...
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Regulatory Affairs Manager
10 hours ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeAt Gilead Sciences, Inc., we're seeking a highly experienced Regulatory Affairs Manager to lead our Global Regulatory team in the development and implementation of regulatory strategies for our Therapeutic Area (TA) portfolio. This role will oversee the preparation and submission of regulatory documents, as well as ensure compliance with global...
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Director of Regulatory Strategy
3 days ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeWe're seeking a strategic and forward-thinking Director of Regulatory Strategy to join our Regulatory Affairs team at Gilead Sciences, Inc. As a key advisor to our business leaders, you'll develop and execute regulatory strategies that drive business growth and minimize risk.The estimated annual salary for this position is $180,000, based on location and...