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Director of Regulatory Affairs
Remote / Online - Candidates ideally in
Fleet, Hampshire County, England, UK
Listed on 2025-11-18
Fleet, Hampshire County, England, UK
Listing for:
TMC Pharma Services Ltd
Full Time, Remote/Work from Home
position Listed on 2025-11-18
Job specializations:
-
Management
Healthcare Management -
Healthcare
Healthcare Management, Healthcare Administration
Job Description & How to Apply Below
This is a full-time hybrid role for a Director of Regulatory Affairs at TMC Pharma Services Ltd. The Director will be responsible for leading regulatory strategy development, overseeing regulatory submissions, and providing cross-functional team leadership. While the role is based in Hartley Wintney, there is flexibility for remote work.
Skills and Experience- required- Life cycle maintenance of CP licences – additional experience in national, MRP, DCP licences welcomed.
- IND compilation
- Preparation of Module 1 documents
- Able to provide strategic leadership during product development from early stages to MAA.
- Coordination of regulatory procedures such as ODDs, PIPs, scientific advice, PRIME etc.
- Coordination of MAAs including pre-submission activities, Rapporteur meetings, oversight of dossier preparation and submission.
- Ability to author clinical, CMC, or non-clinical documents/modules preferred
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