Senior RA CMC Manager, Drug Product

Overview

Senior RA CMC Manager, Drug Product focus – Barrington James (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.Seniority level

Mid-Senior levelEmployment type

Full-timeJob function

Product Management and MarketingIndustries

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