Your new company
Our client, a global biotechnology company focused on developing innovative therapies for rare and serious diseases, is seeking an experienced Regulatory Affairs CMC Manager to join their EU Regulatory team.This is an excellent opportunity to contribute to cutting-edge biologics and advanced therapies, supporting global post-approval strategies and new market applications across both EU and US regions.

Your new role
Reporting to the Senior Director, Regulatory Affairs CMC (EU), you will play a key role in delivering global regulatory CMC strategies for commercial products. You'll collaborate with international teams across Europe and the US to ensure successful execution of regulatory submissions and lifecycle activities.

Act as the Regulatory CMC representative at site and cross-functional meetings, providing clear regulatory guidance.
Lead the planning, coordination, and compilation of high-quality CMC documentation for global post-approval s...