Global Regulatory Affairs Manager

2 weeks ago


London, United Kingdom WALKER COLE INTERNATIONAL LTD Full time

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



  • Uxbridge, Greater London, United Kingdom PE Global Full time

    PE 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...


  • Uxbridge, Greater London, United Kingdom PE Global Full time

    PE 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...


  • Uxbridge, Greater London, United Kingdom PE Global Full time

    Job 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...


  • Uxbridge, Greater London, United Kingdom PE Global Full time

    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. 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...


  • Uxbridge, Greater London, United Kingdom PE Global (UK) Full time

    PE 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...


  • Uxbridge, Greater London, United Kingdom PE Global Full time

    PE 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...


  • Uxbridge, Greater London, United Kingdom PE Global Full time

    PE 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...


  • London, United Kingdom Allen Recruitment Consulting Full time

    Are 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...


  • Uxbridge, Greater London, United Kingdom Park Street People Full time

    An 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 time

    We 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...


  • Surrey Quays, Greater London, United Kingdom EPM Scientific Full time

    The 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...


  • London, United Kingdom Allen Recruitment Consulting Full time

    Are 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...


  • Uxbridge, Greater London, United Kingdom Park Street People Full time

    An 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...


  • Uxbridge, Greater London, United Kingdom CK Group- Science, Clinical and Technical Full time

    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 human...


  • Uxbridge, Greater London, United Kingdom CK Group Full time

    Job 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...


  • London, United Kingdom Compliance Professionals Full time

    Our 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...


  • London, United Kingdom Black Swan Group Full time

    Exciting 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,...


  • London, United Kingdom Black Swan Group Full time

    Exciting 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,...


  • London, United Kingdom Sobi - Swedish Orphan Biovitrum AB (publ) Full time

    Sobi 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...


  • London, United Kingdom Brightwork Ltd Full time

    BaxMed – 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...