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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.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in CMC regulatory affairs for biologics, with a strong understanding of NMPA regulations and experience in antibody product submissions. Capable of collaborating with global teams and influencing the local regulatory landscape.
Highest-signal resume keywords
CMC Regulatory Affairs ExpertiseNMPA Regulations KnowledgeAntibody Product Submissions ExperienceStrong Communication SkillsRegulatory Task Force Participation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
CMC Regulatory AffairsBiologics ExpertiseAntibody SubmissionsRegulatory SubmissionsRegistration Testing
Soft Skills
Strong Communication Skills
Industry Keywords
NMPA RegulationsRegulatory LandscapeRegulatory SupportGlobal CollaborationRegulatory Task Forces
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