Regulatory Affairs Director — Hybrid Strategy & Submissions

TMC Pharma Services Ltd; Fleet; Hybrid; 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

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.