Senior Director, Regulatory CMC

Job overview

The Senior Director, Regulatory CMC role is onsite in South San Francisco, CA. The stated pay range is $258,000–$320,000 per year at commencement, with other compensation elements potentially available. Zai Lab is a biopharmaceutical company developing medicines for patients worldwide. The director leads global CMC regulatory strategy and execution for small-molecule and biologic programs across development phases. The role guides submissions and health-authority interactions, manages regulatory risk, and leads a team to support compliant development and post-approval activities.

What you'll do

• Lead global CMC regulatory submissions for small molecules and biologics, including IND/CTA and NDA/BLA/MAA applications
• oversee dossier preparation, review, and finalization
• develop regulatory strategies across development phases
• serve as primary CMC contact for health authorities
• lead regulatory risk assessment and mitigation
• advise cross-functional teams
• ensure submissions comply with applicable guidelines
• manage and mentor regulatory professionals
• improve internal guidance and processes
• maintain knowledge of evolving requirements
• collaborate with internal stakeholders and external partners.

What we're looking for

Skills & competencies

senior director

regulatory cmc

south san francisco ca

zai lab

biopharmaceutical

small molecules

biologics

global submissions

fda

ema

nmpa

$258k–$320k/year

Work arrangement

• Weekend coverage required

Benefits & perks

• Potential sign-on bonus, restricted stock units, discretionary awards, medical and financial benefits, 401(k) eligibility, and paid time off, depending on position offered.

Why this role

Role based in the South San Francisco office; PhD in a scientific discipline with eight years of regulatory experience or equivalent combination required; English and Chinese communication skills required.

About the employer

Zai Lab (US) LLC is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.