Sr. Manager or Associate Director Regulatory CMC

Scientific Search; Foster City (CA); Hybrid; USD 124,000 - 138,000; Full time

Job summary

Scientific Search is partnering with a top biopharmaceutical company to recruit a Senior Manager/Associate Director Regulatory CMC for full‑time contract support in Foster City. The role is hybrid (2‑3 days onsite) and carries a six‑month contract to permanent conversion with compensation of $90‑100 per hour.

Remote work and relocation are not offered. The expert will lead Regulatory CMC activities for an investigational biologic, supporting clinical and commercial deliverables, including

Qualifications

• Regulatory CMC experience required, including hands‑on submissions and Module 3 content.
• Biologics Regulatory CMC experience required, including health authority interactions and technology transfer.
• Experience with IND/IMPD amendments, BLA/MAA/NDS submissions, and inspection readiness preferred.

Responsibilities

• Support day-to-day Regulatory CMC execution for clinical-stage activities and commercial filing readiness.
• Draft, review, and coordinate CMC submission content for IND/IMPD amendments, CTAs, Global Marketing applications, 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, and regional content alignment.
• Provide operational support for clinical resupply, QP release responses, CDMO follow-up, action item tracking, and time‑sensitive documentation requests.
• Partner with Technical Operations, Quality, Analytical Development, Manufacturing, Regulatory Operations, Supply Chain, QP partners, and 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 experience

Biologics knowledge

IND submissions

Documentation writing

Cross-functional collaboration

Project coordination

Education

Bachelor’s degree in a scientific field

Advanced degree preferred

Job description

Senior Manager/Associate Director Regulatory CMC

Contract to Permanent (6 months).

Location: Hybrid Onsite in Foster City (2-3 days onsite).

Compensation: $90-100HR

Note to Candidates: Remote work and relocation are not offered for this role.

Scientific Search has partnered with a top biopharmaceutical company with multiple rare disease drugs on the market who has tasked us in finding a Senior Manager/Associate Director Regulatory CMC expert who will provide full-time contract support for Regulatory CMC activities for an investigational biologic product. This role will support clinical and commercial CMC deliverables, including submissions, health authority responses, technology transfer, clinical supply, QP release support, and inspection readiness. The position is intended to provide hands‑on execution support and help maintain timely delivery of key regulatory milestones.

Responsibilities

• Support day-to-day Regulatory CMC execution for clinical-stage activities and commercial filing readiness.
• Draft, review, and coordinate CMC submission content for IND/IMPD amendments, CTAs, Global Marketing applications, 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, and regional content alignment.
• Provide operational support for clinical resupply, QP release responses, CDMO follow-up, action item tracking, and time-sensitive documentation requests.
• Partner with Technical Operations, Quality, Analytical Development, Manufacturing, Regulatory Operations, Supply Chain, QP partners, and 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.

Requirements

• Bachelor’s degree in a relevant scientific discipline required; advanced degree preferred. Senior Manager level: typically 6-8 years of Regulatory Affairs CMC experience. Associate Director level: typically 8-10+ years of Regulatory Affairs CMC experience.
• Biologics Regulatory CMC experience required, including hands‑on experience with CMC submissions and Module 3 content.
• Experience with IND/IMPD amendments, BLA/MAA/NDS submissions, health authority responses, technology transfer, manufacturing changes, clinical supply, QP release support, CDMO coordination, or inspection readiness preferred.
• 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.