Global CMC Regulatory Documentation Lead

Bristol Myers Squibb; Moreton; Hybrid; GBP 90,000 - 125,000; Full time

Job summary

Bristol Myers Squibb in the United Kingdom is seeking a Manager, CMC Documentation & Specifications to join our Analytical Strategy & Operations team in Moreton. This role blends science with regulatory excellence, translating complex data into submission-ready content for regulators.

You will author and coordinate CMC sections for regulatory submissions across small molecules, biologics and ADCs, lead specification activities, and respond to Health Authority inquiries with precision and speed.

Qualifications

• Must have 5+ years of pharmaceutical development experience involving small molecules, biologics, and/or ADCs.
• Experience translating complex science into submission-ready regulatory content.
• Excellent written and verbal communication for regulatory submissions.

Responsibilities

• Author CMC regulatory documents translating data into submission-ready content.
• Lead specification activities for small molecules at the interface of development and regulation.
• Coordinate Health Authority inquiries with accurate, timely responses.

Skills

Regulatory writing

Scientific communication

Cross-functional collaboration

Regulatory strategy knowledge

Education

Degree in organic chemistry or related discipline

Tools

Document preparation tools

Job description

Bristol Myers Squibb in the United Kingdom is seeking a Manager, CMC Documentation & Specifications to join our Analytical Strategy & Operations team in Moreton. This role blends science with regulatory excellence, translating complex data into submission-ready content for regulators.

You will author and coordinate CMC sections for regulatory submissions across small molecules, biologics and ADCs, lead specification activities, and respond to Health Authority inquiries with precision and speed.