Regulatory CMC Contractor

Barrington James; United States; On-site; USD 165,000 - 248,000; Full time

Job summary

Barrington James is seeking a Senior Manager/Associate Director Regulatory CMC contractor to provide full-time support for Regulatory CMC activities on a late-stage mAb program, delivering timely milestones for a BLA filing.

You will perform hands-on execution, draft and review Module 3 content, coordinate responses to health authorities, support technology transfers and inspections, and partner with CDMOs to ensure filing readiness and quality.

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.

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

Skills

Regulatory CMC

Biologicals experience

CMC submissions

IND/IMPD/BLA

Project coordination

Independent work

Job description

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.