Regulatory CMC Contractor

Senior Manager/Associate Director Regulatory CMC contractor will provide full-time contract support for Regulatory CMC activities for a late stage mAb programme. The contractor will provide hands-on execution support and help maintain timely delivery of key regulatory milestones for a BLA filing.

RESPONSIBILITIES

• Support day-to-day Regulatory CMC execution for late stage development and commercial filing readiness
• Draft, review, and coordinate CMC submission content for BLA, post-approval variations, supplements, annual reports, briefing packages, and health authority responses
• Support scale-up, technology transfer, manufacturing change assessments, Module 3 readiness, source document tracking
• Partner cross-functionally and with CDMOs to support documentation quality and filing timelines; support product and GMP inspection readiness, including anticipated CMC questions, source document alignment, issue tracking, and commitment follow-up

QUALIFICATIONS

• 6-10 years Reg CMC experience with Biologicals
• Hands-on experience with CMC submissions and Module 3 content, experience with IND/IMPD amendments, BLA/MAA submissions and health authority responses
• Experience with technology transfers, manufacturing changes, clinical supply, QP release support, CDMO coordination and inspection readiness
• Strong writing, document review, project coordination, action tracking and issue-management skills.
• Ability to work independently, manage multiple priorities, and support time-sensitive deliverables in a cross-functional environment.