Global Regulatory Affairs Manager
2 weeks ago
Walker Cole International are looking for a Senior Regulatory Affairs Associate to join an exciting clinical-stage Biopharmaceutical company in the UK. In this role you will be responsible for the development and execution of regulatory submissions for thebusiness' projects.
You will be responsible for:
- The maintenance of regulatory files and databases including the Trial Master File.
- The preparation, risk analysis and planning of submissions for assigned programs and projects.
- Collaborate with both internal and external stakeholders to support the execution of regulatory submissions.
- Maintaining oversight and working knowledge of relevant laws, guidelines and requirements.
- A Bachelor's degree in a scientific field.
- An understanding of the drug product lifecycle from R&D through to marketing.
- An understanding of pre-clinical and clinical drug development.
- A working knowledge of FDA, EMA and ICH regulatory guidelines.
Regulatory Affairs | RA | Senior Regulatory Affairs Officer | GMP | Pharmaceutical | Regulatory | Submission | Product Dossiers | EU | Global | MHRA | FDA | Good Manufacturing Practice | CTD | Common Technical Documentation | Module 1 | Module 2 | Module3 | Module 4 | Module 5 | TMF | Trial Master File | Clinical | R&D
-
Director of Policy and Regulatory Affairs
5 days ago
Uxbridge, Greater London, United Kingdom PE Global Full timePE Global is recruiting for a UK regulatory affairs manager for our leading pharmaceutical client in Uxbridge on an initial 12-month hybrid contract. Responsible for the generation of country specific regulatory strategies and providing feedback to internal teams regarding submission plans and execution of the strategy for one or more products. Ensuring...
-
Director of Policy and Regulatory Affairs
6 days ago
Uxbridge, Greater London, United Kingdom PE Global Full timePE Global is recruiting for a UK regulatory affairs manager for our leading pharmaceutical client in Uxbridge on an initial 12-month hybrid contract. Responsible for the generation of country specific regulatory strategies and providing feedback to internal teams regarding submission plans and execution of the strategy for one or more products. Ensuring...
-
Regulatory Affairs Manager
1 week ago
Uxbridge, Greater London, United Kingdom PE Global Full timeJob Description PE Global is recruiting a Regulatory Affairs Manager (CTA) for our multinational pharmaceutical client based in Uxbridge. The role is hybrid and an initial 12-month contract. Responsibilities of the role: Advising the GRT on regional considerations in developing strategy Ensuring the regional needs are well defined and implemented in...
-
Director of Policy and Regulatory Affairs
2 weeks ago
Uxbridge, Greater London, United Kingdom PE Global Full timePE Global is recruiting a Regulatory Affairs Manager (CTA) for our multinational pharmaceutical client based in Uxbridge. The role is hybrid and an initial 12-month contract. May participate as a member of: Global Regulatory Team (GRT) Global Development Team (GDT) Clinical Study Team (CST) Label Working Group (LWG) Regional Teams (e.g. Act as a contact...
-
Director of Policy and Regulatory Affairs
3 days ago
Uxbridge, Greater London, United Kingdom PE Global (UK) Full timePE Global is recruiting for a UK regulatory affairs manager for our leading pharmaceutical client in Uxbridge on an initial 12-month hybrid contract. Responsible for the generation of country specific regulatory strategies and providing feedback to internal teams regarding submission plans and execution of the strategy for one or more products. Ensuring...
-
UK CW Regulatory Affairs Manager
5 days ago
Uxbridge, Greater London, United Kingdom PE Global Full timePE Global is recruiting for a UK regulatory affairs manager for our leading pharmaceutical client in Uxbridge on an initial 12-month hybrid contract. Responsibilities: Responsible for the generation of country specific regulatory strategies and providing feedback to internal teams regarding submission plans and execution of the strategy for one or more...
-
UK CW Regulatory Affairs Manager
6 days ago
Uxbridge, Greater London, United Kingdom PE Global Full timePE Global is recruiting for a UK regulatory affairs manager for our leading pharmaceutical client in Uxbridge on an initial 12-month hybrid contract. Responsibilities: Responsible for the generation of country specific regulatory strategies and providing feedback to internal teams regarding submission plans and execution of the strategy for one or more...
-
Regulatory Affairs Manager
2 weeks ago
London, United Kingdom Allen Recruitment Consulting Full timeAre you an experienced Regulatory Affairs professional with a background in Chemistry, Manufacturing and Controls and experience working in the Biopharmaceutical/Biotechnology industry, and are you looking for a new opportunity? We have your next role, we are recruiting for a Regulatory Affairs CMC Manager with Post Approval Submissions and who has...
-
Regulatory Affairs Manager
2 weeks ago
Uxbridge, Greater London, United Kingdom Park Street People Full timeAn innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and early stage development experience to join their team on a 12 month temporary contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the...
-
Sds Author
1 month ago
London, United Kingdom VRS Regulatory Full timeWe are looking for a Safety Data Sheet / SDS Author / Regulatory Officer for a London based consumer products company. Your role will be varied and include researching pending changes developments to global chemical regulations, developing regulatory documents (SDSs, labels etc) for new and existing products, and providing regulatory support to internal...
-
Director Global Regulatory Affairs
2 days ago
Surrey Quays, Greater London, United Kingdom EPM Scientific Full timeThe Director, Global Regulatory Affairs will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives. The following information aims to provide potential candidates with a better understanding of the requirements...
-
Senior Manager/Director of Regulatory Affairs
2 weeks ago
London, United Kingdom Allen Recruitment Consulting Full timeAre you an experienced Regulatory Affairs professional with a background in Chemistry, Manufacturing and Controls and experience working in the Biopharmaceutical/Biotechnology industry, and are you looking for a new opportunity? We have your next role, we are recruiting for a Regulatory Affairs CMC Manager with Post Approval Submissions and who has...
-
Regulatory Affairs Manager
2 weeks ago
Uxbridge, Greater London, United Kingdom Park Street People Full timeAn innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and early stage development experience to join their team on a 12 month temporary contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the...
-
Regulatory Affairs Manager
2 weeks ago
Uxbridge, Greater London, United Kingdom CK Group- Science, Clinical and Technical Full timeCK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company who are based in Uxbridge on a contract basis for 12 months. Company: Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human...
-
Regulatory Affairs Manager
1 week ago
Uxbridge, Greater London, United Kingdom CK Group Full timeJob Description CK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company who are based in Uxbridge on a contract basis for 12 months. Company: Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative...
-
Regulatory affairs senior
2 weeks ago
London, United Kingdom Compliance Professionals Full timeOur client is a successful banking firm with a strong global presence, offering a comprehensive range of services across corporate and investment banking activities. Act as a subject matter expert in Regulatory Affairs. Maintain an effective, professional and proactive relationship with UK regulators and assist the Local Compliance Officers in dealing...
-
Regulatory Affairs Officer
2 weeks ago
London, United Kingdom Black Swan Group Full timeExciting Opportunity for Regulatory Affairs AVP: Are you a regulatory compliance expert seeking your next career move? My client are a Global banking organisation on the lookout for a talented individual to join our team as a Regulatory Affairs Assistant Vice President (AVP). Key Responsibilities: Develop and maintain relationships with UK regulators,...
-
Regulatory Affairs Officer
2 weeks ago
London, United Kingdom Black Swan Group Full timeExciting Opportunity for Regulatory Affairs AVP: Are you a regulatory compliance expert seeking your next career move? My client are a Global banking organisation on the lookout for a talented individual to join our team as a Regulatory Affairs Assistant Vice President (AVP). Key Responsibilities: Develop and maintain relationships with UK regulators,...
-
International Regulatory Affairs Manager
1 month ago
London, United Kingdom Sobi - Swedish Orphan Biovitrum AB (publ) Full timeSobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere. The Manager, Regulatory...
-
Regulatory Affairs Consultant
4 weeks ago
London, United Kingdom Brightwork Ltd Full timeBaxMed – Ad-Hoc Senior Regulatory Affairs Consultant Led by Stuart Baxter, a seasoned professional with a distinguished career in Regulatory Affairs, BaxMed Regulatory Ltd is an exciting early-stage organisation formed to provide Regulatory and Quality Compliance Services for the global Medical Device / healthcare sector. With a core ethos and commitment...