Director CMC RA

headcount; Basel; On-site; CHF 180,000 - 240,000; Full time

Job summary

Headcount is seeking a Director of Regulatory Affairs CMC Europe to lead the regulatory strategy for novel small-molecule therapies in oncology. This role requires steering global CMC development, submissions and lifecycle management across clinical, regulatory and manufacturing functions, with a focus on Module 3 and interactions with FDA/EMA.

The candidate will collaborate across Development, Quality and Supply Chain to ensure timely, successful global submissions while shaping the strategy

Qualifications

• Significant experience in Regulatory Affairs CMC within pharmaceutical/biotech industry.
• Strong background in small molecules and 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.

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 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.

Skills

Regulatory Affairs CMC

Small molecules

NCEs

Global submissions

Module 3

Health Authority interactions

Oncology experience

Job description

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.