Head of Regulatory Affairs
20 hours ago
- Serve as the key contact on issues relating to the implementation of and compliance with Bicycle's Code of Business Conduct & Ethics and related policies
- Develop, implement, and maintain a comprehensive healthcare and corporate compliance and ethics program, ensuring alignment across all functions, including clinical development, medical affairs, and commercial teams
- Ensure compliance with global healthcare and corporate compliance-related requirements, industry standards, and internal policies across all functions
- Partner with cross-functional teams to embed ethical decision-making into clinical trials, product development, and commercial strategies
- Lead healthcare and corporate compliance training programs tailored to the unique needs of the company
- Oversee healthcare and corporate compliance-based risk assessments and internal audits/monitoring to proactively identify and address compliance vulnerabilities
- Collaborate with leadership to integrate compliance into strategic decision-making processes
- Manage reporting, investigations, and resolution of compliance violations
In this role, you will have the opportunity to work closely with Regulatory Affairs teams to stay up-to-date with international and regional laws and regulations and ensure the company's adherence to these requirements.
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Regulatory Affairs Director
1 day 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 Coordinator
4 days ago
Cambridge, Cambridgeshire, United Kingdom INTERNET WATCH FOUNDATION Full timeRole OverviewWe are seeking a highly skilled Policy Manager to join our team at the Internet Watch Foundation (IWF).In this role, you will be responsible for shaping IWF's policy positions and achieving real-world change through legislation, regulatory frameworks, and industry practice.As a Policy Manager, you will work closely with the Head of Policy &...
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Regulatory Affairs Director
1 day 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 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
4 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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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 Expert
4 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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Regulatory Affairs Manager
23 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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Regulatory Affairs Manager
1 day 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...
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Regulatory Affairs Professional
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom ProductLife Group Full timeAbout the JobIn a continuous effort to grow and expand our services, ProductLife Group is looking for a Regulatory Affairs Specialist to join our team in the United Kingdom.This position plays a vital role in developing our local UK Regulatory Affairs presence, overseeing new regulatory activities related to the UK for multiple clients. You will work closely...
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Regulatory Affairs Specialist
1 day ago
Cambridge, Cambridgeshire, United Kingdom Dr. Reddy's Laboratories Full timeKey Role in UK Regulatory AffairsA key position has become available in our UK location for an EU Regulatory Affairs Specialist. As a vital member of our team, you will play a crucial role in supporting the preparation and submission of regulatory documentation for marketing authorization applications in the UK.Main Responsibilities:Preparation and...
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Regulatory Affairs Specialists
4 days ago
Cambridge, Cambridgeshire, United Kingdom Vertex Ventures HC Full timeJob Title: Compliance OfficersEstimated Salary: $85,000 - $110,000 per year.Bicycle Therapeutics is a pioneering pharmaceutical company dedicated to developing innovative treatments for complex diseases. As a Senior Associate in Regulatory Affairs, you will play a critical role in shaping the company's regulatory strategy, ensuring compliance with global...
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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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Regulatory Affairs Strategy Lead
3 days ago
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Strategy Lead to join our team at MoonLake Immunotherapeutics.This is an exceptional opportunity for a seasoned professional with expertise in regulatory affairs and a passion for innovative global strategies to drive drug development.
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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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Quality Assurance and Regulatory Affairs Expert
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full timeJob Description: Quality Assurance and Regulatory Affairs ExpertCompany Overview:Newton Colmore Consulting is a leading consulting firm in the medical devices industry, providing expert advice on regulatory affairs and quality assurance. We are committed to delivering high-quality services that meet the needs of our clients, and we are seeking a talented...
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Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full timeJob Title: Regulatory Affairs and Quality Assurance ProfessionalAbout the Role:We are seeking a skilled Regulatory Affairs and Quality Assurance Professional to join our team at Newton Colmore Consulting. As a key member of our R&D team, you will play a vital role in ensuring compliance with FDA 510k, ISO 13485, and FDA 21 CFR Part 820 standards for new...
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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...