Associate Director Regulatory Affairs CMC
Company: Meet Life Sciences Agency
- Location: United Kingdom
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Associate Director, CMC Regulatory Affairs
I'm currently supporting an exciting opportunity for an Associate Director, CMC Regulatory Affairs to provide strategic leadership across global regulatory activities for both development-stage and commercial pharmaceutical products.
Key responsibilities include:
- Developing and leading global CMC regulatory strategies.
- Leading CMC contributions to global regulatory submissions, including Module 3 documentation.
- Supporting product registrations, post-approval changes and lifecycle management.
- Leading CMC-related health authority interactions and regulatory responses.
- Providing regulatory guidance across manufacturing, pharmaceutical development and quality.
- Collaborating with global cross-functional teams across Technical Operations, Quality, Supply Chain and Regulatory Affairs.
What we're looking for:
- 8–10+ years of pharmaceutical industry experience, with significant Regulatory CMC expertise.
- Strong experience with global regulatory submissions and Module 3 documentation.
- Good understanding of EU/UK regulatory requirements, GMP and ICH guidelines.
- Experience supporting both development and commercial products.
- Confident providing strategic regulatory guidance and leading cross-functional projects.
Experience with biologics, cell and gene therapies or combination products would be advantageous.
eireann.evans@meetlifesciences.com
