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Senior Principal Scientist, CMC Regulatory Affairs – Biological Products
Johnson & JohnsonPrincipal Scientist specializing in CMC regulatory affairs for biologics. Collaborating with global teams and supporting registration processes under NMPA guidelines.
About the role
Key responsibilities & impact- Provide CMC regulatory support for submissions in China
- Collaborate with global teams on registration testing
- Support initiatives to influence local regulatory landscape
- Participate in regulatory task forces
Requirements
What you’ll need- Expertise in CMC regulatory affairs for biologics
- Knowledge of NMPA regulations
- Experience in antibody product submissions
- Strong communication skills
Benefits
Comp & perks- Inclusive work environment
- Opportunities for innovative medicine development
ATS Keywords
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Hard Skills & Tools
CMC Regulatory AffairsBiologics ExpertiseAntibody SubmissionsRegulatory SubmissionsRegistration Testing
Soft Skills
Strong Communication Skills