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Senior Principal Scientist, CMC Regulatory Affairs - Biological
Johnson & JohnsonProvide regulatory support for CMC submissions in China focusing on antibody products. Collaborate with global teams and influence local regulatory environment.
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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
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Hard Skills & Tools
CMC regulatory supportBLA preparationregistration testingbiological product filings
Soft Skills
communicationcollaborationguidance