Senior RA CMC Manager, Drug Product

Barrington James Limited; France; Hybride; EUR 60 000 - 90 000; Plein temps

Résumé du poste

A pharmaceutical consulting firm in Central France is seeking a CMC Manager to lead Drug Product strategy and mentor a direct report. The role involves drafting regulatory documents and partnering with technical teams to ensure compliance. Ideal candidates will have a strong CMC background and experience in regulatory writing, especially in Fill/Finish environments. Competitive salary range of €60K-90K is offered.

Qualifications

• Strong technical CMC foundation, ideally in a DP/formulation or Fill/Finish environment.
• Experience with bioconjugates or small molecules.
• Regulatory writing experience and translation of technical knowledge.

Responsabilités

• Take ownership of Drug Product CMC strategy with a focus on Fill/Finish activities.
• Draft clinical and commercial dossiers ensuring compliance with EU/FDA.
• Outline development pathways and fast-track options.
• Review and approve validation protocols and source documents.
• Partner with process development, manufacturing, and QA.
• Act as regulatory contact for internal and external teams.
• Mentor and lead 1 direct report.

Connaissances

Regulatory writing

Technical CMC knowledge

Formulation and stability

Bioconjugates or small molecules

Description du poste

Must be based in 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.