Regulatory Affairs Specialist
1 month ago
We are seeking an experienced Regulatory Affairs Specialist to join our team at Vertex Ventures HC. In this role, you will play a critical part in ensuring the regulatory compliance of our cancer therapies.
As a key member of our Regulatory Affairs team, you will be responsible for developing and executing global regulatory strategies for assigned programs or projects. You will work closely with cross-functional colleagues to ensure timely execution of regulatory submissions, responses to questions, audits, and inspections.
The ideal candidate will have a bachelor's degree in a scientific field or post-graduate degree, with a minimum of 2 years experience in the pharmaceutical or biotechnology industry. They will possess demonstrable knowledge of the role of Regulatory Affairs within the pharmaceutical or biotechnology industry, as well as working knowledge of FDA, EMA, and ICH regulatory guidance and regulations.
In addition to these qualifications, the successful candidate will have therapeutic experience in oncology, ability to communicate on topics of basic science, and strong organizational and time management skills.
Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We offer a competitive rewards package, including annual company bonus, employee recognition schemes, and comprehensive benefits such as life assurance cover, private medical insurance, and access to company-subsidized gym membership.
Key Responsibilities:- Develop and execute global regulatory strategies for assigned programs or projects
- Maintain regulatory files and tracking databases, including relevant parts of the trial master file
- Collaborate with internal colleagues and external organizations to support timely execution of regulatory submissions, responses to questions, audits, and inspections
- Bachelor's degree in a scientific field or post-graduate degree preferred
- Minimum of 2 years experience in the pharmaceutical or biotechnology industry
- Demonstrable knowledge of the role of Regulatory Affairs within the pharmaceutical or biotechnology industry desirable
$120,000 - $150,000 per annum, depending on experience. State-of-the-art campus environment with on-campus restaurant and Montessori nursery. Flexible working environment. Annual company bonus.
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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 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
2 days 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 Specialist
6 days 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 Specialist
2 days ago
Cambridge, Cambridgeshire, United Kingdom Dr. Reddy's Laboratories Full timeJob Title: Regulatory Affairs SpecialistAbout Us:Dr. Reddy's Laboratories is a leading multinational pharmaceutical company based globally with over 24,000 employees.We accelerate access to affordable and innovative medicines for better health outcomes worldwide.Location: Dr. Reddy's (UK) Ltd, Cambridge (UK)Job Description:This role involves the preparation...
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Regulatory Affairs Specialist
1 week 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 Director
6 days 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 Specialists
1 week 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
6 days 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
1 week 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 Expert
4 days 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 Bicycle Therapeutics Full timeCompany OverviewBicycle Therapeutics is a pioneering pharmaceutical company pushing the boundaries of innovation in drug development. Our mission is to create life-changing therapies for underserved diseases.About the RoleWe are seeking a skilled Senior Associate, Regulatory Affairs to join our team. As a key member of our regulatory department, you will be...
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Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeNewton Colmore Consulting Ltd is a leading recruitment specialist in Medical Devices, Science, and Biotech. We are looking for a talented Regulatory Affairs and Quality Assurance Assistant to join our team. This role involves supporting the Quality Assurance and Regulatory Affairs Manager in ensuring compliance with industry standards and...
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Cambridge, Cambridgeshire, United Kingdom ProductLife Group Full timeAbout the JobWe are seeking an experienced Regulatory Affairs Specialist to join our team at ProductLife Group in the UK. As a key member of our regulatory affairs division, you will play a crucial role in ensuring compliance with UK and European regulations for nutrition and health products.Responsibilities:Review product formulations and labels to ensure...
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External Affairs Specialist
1 week ago
Cambridge, Cambridgeshire, United Kingdom The Right Ethos - Specialist External Affairs Recruitment Full timePeterborough and surrounding areas is home to Cambridgeshire, Peterborough and South Lincolnshire Mind (CPSL Mind), a values-based mental health charity working towards collaborative recovery services.About the Role:The External Affairs Specialist will join our established Communications Team, focused on promoting CPSL Mind's services and increasing income...
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Regulatory Affairs Expert
1 week 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
6 days 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 Director
2 days 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 Manager
6 days 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 Manager
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom ProTech Recruitment Ltd Full timeRegulatory Compliance SpecialistA renowned healthcare technology company is seeking a highly motivated Regulatory Affairs Manager to lead their regulatory compliance efforts across international markets. This individual will play a critical role in guiding the organization's innovative medical products through the regulatory approval process, ensuring...