Senior RA CMC Manager, Drug Product

Barrington James Limited; Greater London; On-site; GBP 52,000 - 79,000; Full time

Job summary

A leading regulatory consulting firm is seeking a Senior Manager for Regulatory Affairs with a focus on Drug Product CMC, specifically Fill/Finish activities. This role involves drafting compliance dossiers, reviewing validation protocols, and mentoring a direct report. Ideal candidates should have a strong technical background in CMC and regulatory writing experience. The position offers a hybrid work model with onsite and remote options.

Qualifications

• Strong technical CMC foundation from a DP/formulation or Fill/Finish environment.
• Experience with bioconjugates or small molecules.
• Ability to translate technical knowledge into regulatory language.

Responsibilities

• Take ownership of Drug Product CMC strategy focused on Fill/Finish activities.
• Draft clinical and commercial dossiers ensuring compliance with EU/FDA expectations.
• Outline development pathways to accelerate timelines.
• Review and approve validation protocols and source documents.
• Partner with process development, manufacturing, and QA for alignment.
• Act as a regulatory point of contact for internal and external teams.
• Mentor and lead a direct report in their professional development.

Skills

Regulatory writing

Technical CMC knowledge

Bioconjugates experience

Fill/Finish expertise

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.