Director, Regulatory Affairs CMC Europe

Ready to lead the CMC regulatory strategy for novel small-molecule therapies in oncology?

We’re partnering with an innovative biotechnology company that is advancing a portfolio of next-generation targeted oncology therapies. As the pipeline progresses towards global registrations, we’re looking for an experienced Director, Regulatory Affairs CMC – Europe to shape global CMC strategy and play a key role in bringing breakthrough medicines to patients.

Your Responsibilities

• Lead the global CMC regulatory strategy for innovative small-molecule development programmes.
• Drive CMC activities across clinical development, registration and lifecycle management.
• Develop and oversee global CMC submission strategies, including Module 3.
• Lead interactions with global Health Authorities, including the FDA and EMA.
• Partner closely with Technical Development, Quality, Manufacturing and Supply Chain to ensure successful global submissions.
• Assess regulatory risks and provide strategic guidance throughout product development.

What We’re Looking For

• Significant experience in Regulatory Affairs CMC within the pharmaceutical or biotechnology industry.
• Strong background in small molecules, ideally New Chemical Entities (NCEs).
• Experience developing and executing global CMC regulatory strategies from clinical development through registration and lifecycle management.
• Strong knowledge of Module 3, global CMC submissions and Health Authority interactions.
• Oncology experience is highly desirable.
• A collaborative leader who thrives in a fast-paced, science-driven biotech environment.

Why Join? This is an opportunity to join a highly innovative biotechnology company at an exciting stage of growth. You’ll have a direct impact on the global regulatory strategy of a promising oncology pipeline while working alongside internationally recognised experts in drug development.

Interested?
We’d love to tell you more. Apply today or contact Julian Nelle, Managing Consultant at headcount