Senior Regulatory Affairs Manager – CMC Biologics

About the role

Our client, a global biotechnology company, is seeking a Senior Regulatory Affairs Manager to lead CMC activities for biologics. Reporting to the Senior Director, Regulatory Affairs CMC (EU), you will shape global post‑approval strategies and support new market applications across the EU and US.

Key responsibilities

• Develop and execute global regulatory CMC strategies for commercial biologic products.
• Coordinate and compile high‑quality CMC documentation for post‑approval submissions.
• Ensure all submissions meet EU, FDA and other applicable regulatory requirements.
• Represent Regulatory CMC in site and cross‑functional meetings, providing clear guidance.
• Partner with international teams to manage change controls, GMP documentation and product lifecycle activities.
• Identify risks and devise mitigation strategies, supporting interactions with global authorities.

Required profile

• Extensive experience in Regulatory Affairs CMC, preferably within biologics, biotechnology or advanced therapies.
• Proven track record with post‑approval submissions and product lifecycle management.
• Significant FDA experience combined with solid knowledge of EU regulations.
• Demonstrated ability to manage complex projects and global stakeholder relationships.

Required skills

What we offer

• Flexible working options, including remote work.