Senior Principal Scientist, CMC Regulatory Affairs - Biological

Johnson & Johnson

Provide regulatory support for CMC submissions in China focusing on antibody products. Collaborate with global teams and influence local regulatory environment.

Posted 6/25/2026full-timeBeijing • 🇨🇳 ChinaSeniorWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CMC regulatory supportBLA preparationregistration testingbiological product filings

Soft Skills

communicationcollaborationguidance

Industry Keywords

pharmaceutical industrybiotechnology industryNIFDCPFDAregulatory compliance

About the role

Key responsibilities & impact

Provide CMC regulatory support for submissions in China
Focus on antibody products and BLA preparation
Ensure registration testing support at NIFDC or PFDA Laboratories
Participate in task forces and comment on regulations
Guide local, regional, and global associates

Requirements

What you’ll need

Broad regulatory and technical expertise
Experience with CMC regulatory supports
Communication with global CMC RA and DPDS functions
Support biological product filings
Experience in pharmaceutical or biotechnology industry

Benefits

Comp & perks

Inclusive work environment
Consultation with global CMC RA and DPDS functions
Opportunities to influence local regulatory environment