Regulatory Affairs Specialist
11 hours ago
A 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 Submission: Prepare and submit UK national MAA procedures, variations, and renewal procedures, including Module 1, 2, and 3.
- Regulatory Coordination: Coordinate with internal and external contacts, including regulatory authorities, European affiliates, Headquarter, and partners/customers.
- Review and Assessment: Review registration dossiers prior to each submission step during the MAA filing process for in-house developments and licensed products in the UK.
- Product Launch Support: Provide support for product launch activities.
- Ongoing Activities: Participate in other regulatory-related activities, including variation submissions for UK manufacturing licenses, PIL and SmPC uploads on the eMC website, review and approval of UK packaging materials artworks, tracking of Sunset Clause activities, and assistance in obtaining Certificates of a Pharmaceutical Product and notarization/legalization where required.
This full-time role offers a salary of £45,000 - £55,000 per annum, depending on experience, and benefits package including generous annual leave, pension scheme, and professional development opportunities.
-
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...
-
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...
-
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.
-
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...
-
Regulatory Affairs Specialists
3 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...
-
Regulatory Affairs Director
11 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...
-
Regulatory Affairs Specialist
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Vertex Ventures HC Full timeWe 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...
-
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...
-
Regulatory Affairs Director
14 hours 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...
-
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...
-
Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full timeCpl Life Sciences is seeking a highly experienced Lead Regulatory Affairs Specialist to join our team in Cambridge, UK. This is a unique opportunity to work with a prestigious global drug development consultancy business that specialises in supporting pharma, biotechs, spin-outs, and academic groups with drug development activities.The successful candidate...
-
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...
-
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...
-
External Affairs Specialist
3 days 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...
-
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...
-
Regulatory Affairs Manager
9 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...
-
Regulatory Affairs Manager
13 hours 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...
-
Regulatory Affairs Manager
3 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...
-
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...
-
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.