Senior RA CMC Manager, Drug Product
- Horley, Surrey
- Permanent
- Full-time
✈️ Bi-monthly travel to Switzerland
👥 1 direct report
💶 Salary range: €60K-90KResponsibilities: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.