Senior RA CMC Manager, Drug Product
Listed on 2025-12-06
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Healthcare
Healthcare Management -
Management
Healthcare Management
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
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.
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.
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