Director of Regulatory Affairs

TMC Pharma Services Ltd; Fleet; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical service provider in Fleet is seeking a Director of Regulatory Affairs to lead the regulatory strategy and oversee submissions. This full-time hybrid role includes providing cross-functional leadership and coordinating regulatory procedures, ensuring effective product development from early stages to MAA. Ideal candidates will have experience in life cycle maintenance of CP licences, IND compilation, and preparation of Module 1 documents.

Qualifications

• Experience in life cycle maintenance of CP licences, including national, MRP, and DCP licences.
• Skilled in IND compilation.
• Ability to prepare Module 1 documents.

Responsibilities

• Lead regulatory strategy development and oversee submissions.
• Provide cross-functional team leadership.
• Coordinate regulatory procedures and MAAs.

Skills

Life cycle maintenance of CP licences

IND compilation

Preparation of Module 1 documents

Strategic leadership during product development

Coordination of regulatory procedures

Coordination of MAAs

Job description

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