Role Summary
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.
Preferred:
- Ability to author clinical, CMC, or non-clinical documents/modules preferred
- US regulatory experience useful