Senior RA CMC Manager, Drug Product

Posted 7 hours ago by Barrington James Limited

Permanent
Full Time
Other
London, United Kingdom
Job Description
Senior Manager, Regulatory Affairs CMC (Drug Product focus) - Central France

4 days on site / 1 day remote
️ Bi-monthly travel to Switzerland
1 direct report
Salary range: €60K-90K

Responsibilities:

  • Take ownership of Drug Product (DP) CMC strategy, with strong focus on Fill/Finish activities, formulation, and stability programs.

  • Draft clinical and commercial dossiers from scratch (IMPDs, INDs, BLAs/MAAs), ensuring compliance with EU/FDA expectations.

  • Outline development pathways and fast-track options to accelerate timelines.

  • Review and approve validation protocols (analytical/stability) and source documents provided by development and QC teams.

  • Partner closely with process development, manufacturing, and QA to ensure alignment between tech ops and regulatory deliverables.

  • Act as a regulatory point of contact for internal teams and external collaborators.

  • Mentor and lead 1 direct report, supporting their professional development.

Ideal Background:

  • Strong technical CMC foundation, ideally coming from a DP/formulation or Fill/Finish environment.

  • Experience with bioconjugates or small molecules.

  • Regulatory writing experience, with the ability to translate technical knowledge into regulatory language.