Regulatory Affairs Director
3 days ago
Bicycle Therapeutics is a pioneering pharmaceutical company developing innovative medicines for underserved diseases. As Associate Director, Regulatory Affairs CMC, you will play a pivotal role in shaping the regulatory strategy and submissions for our assigned programs or projects.
Key Responsibilities- Develop and execute global regulatory CMC strategies and submissions for assigned programs or projects.
- Collaborate with internal colleagues and external organizations to develop submission content plans and timelines.
- Manage the preparation, drafting, review, risk analysis, and mitigation planning of CMC submissions.
- Maintain internal cross-functional relationships to support the development and execution of CMC regulatory submissions.
- Bachelor's degree in a scientific field or post-graduate degree preferred.
- Extensive experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Working knowledge of FDA, EMA, ICH, and cGMP CMC regulatory guidance and regulations.
- Estimated salary: $120,000 - $180,000 per annum, depending on experience.
- State-of-the-art campus environment with on-campus restaurant and Montessori nursery.
- Flexible working environment.
- Competitive rewards, including annual company bonus and employee recognition schemes.
- 28 days annual leave plus bank holidays and option to buy additional days.
- Pension contribution and life assurance cover.
- Private medical insurance and employee assistance program.
- Cycle-to-work scheme.
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Regulatory Affairs Director
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full timeJob Title: Regulatory Affairs DirectorWe 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...
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Regulatory Affairs Director
2 weeks 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
3 days ago
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeJob Title: Regulatory Affairs DirectorMoonLake Immunotherapeutics invites applications for a talented Regulatory Affairs Director to join our team. In this critical role, you will lead the development and execution of global regulatory strategies for sonelokimab lead indication(s).The successful candidate will have extensive experience in regulatory affairs,...
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Regulatory Affairs Director
1 week ago
Cambridge, Cambridgeshire, United Kingdom Indo Search Full timeIndo Search is a ground-breaking developer of high-end medical technologies with ambitious plans to scale globally.We are seeking an experienced Regulatory Affairs Director to lead our regulatory team in achieving global compliance for complex Class IIb/III devices.The ideal candidate will have extensive senior-level experience in medical device regulatory...
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Regulatory Affairs Director
2 weeks 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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Compliance and Regulatory Affairs Director
4 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 Expert
2 weeks 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 Sobi group Full timeJoin Sobi's Team: We are seeking an experienced Associate Medical Director, Regulatory Affairs to join our team of experts in clinical development and regulatory affairs.About the Role: The successful candidate will be responsible for leading clinical development activities, providing scientific and medical input to clinical study documents, and...
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Senior Director Regulatory Guidance
2 weeks 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
2 weeks 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
2 weeks 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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Regulatory Affairs Expert
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom VCLS Full timeWe are seeking a highly experienced Regulatory Affairs Expert to join our growing team at VCLS. This role is ideal for someone with 4+ years of experience in regulatory affairs and a strong background in Clinical Trial Submissions.The successful candidate will play a key role in driving forward regulatory processes, ensuring compliance, and contributing to...
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Regulatory Affairs Specialist
3 days ago
Cambridge, Cambridgeshire, United Kingdom Vectura Group plc Full timeJob SummaryVectura Group plc is seeking a highly skilled Regulatory Affairs Specialist to lead our medical device regulatory activities. This role involves assuming the role of Regulatory Affairs Manager with specialized expertise in medical devices and drug-device combination products (DDCPs). About Vectura Group plcWe are a global leader in developing...
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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
1 month 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
1 month 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 Specialist
1 week ago
Cambridge, Cambridgeshire, United Kingdom Dr. Reddy's Laboratories Full timeJob Title: Regulatory Affairs SpecialistEstimated Salary: $80,000 - $110,000 per annumAbout UsWe are a leading multinational pharmaceutical company based across global locations. Our mission is to accelerate access to affordable and innovative medicines.Job DescriptionThe successful candidate will be responsible for preparation and submission of UK MAA...
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Regulatory Affairs Manager
2 weeks 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
2 weeks 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...
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Regulatory Affairs Manager
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Gilead Full timeAbout GileadGilead Sciences, Inc. is a global biopharmaceutical company dedicated to developing innovative treatments for life-threatening diseases. We're looking for talented individuals to join our team as Regulatory Affairs Manager.Job DescriptionThis role will act as the Regional Regulatory Lead on complex or multiple products, compounds, indications or...