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Director of Regulatory Affairs

TMC Pharma Services Ltd
Hook
1 month ago
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Senior Director, Regulatory Affairs - CMC, Regulatory Operations & Lifecycle Management

Company

TMC Pharma Services Ltd, based in Hartley Wintney, provides expert support services to the pharmaceutical industry with a focus on drug development, regulatory affairs, consultancy, and post-approval/marketing support. The team excels in delivering successful projects and thrives on tackling unique challenges. TMC collaborates with clients ranging from biotech start-ups to multinational corporations in Europe, the USA, and worldwide.


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:

  1. Ability to author clinical, CMC, or non-clinical documents/modules preferred
  2. US regulatory experience useful

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