Senior Scientist, Product Lead CMC Regulatory Affairs
Johnson & Johnson · Titusville, NJ +3 more
RegulatoryFull-time$109k–$175kCompany career page
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Role summary
Senior Scientist Product Lead role in CMC Regulatory Affairs at Johnson & Johnson's Innovative Medicine division. Responsible for developing global regulatory strategies, leading CMC teams, and supporting health authority submissions for synthetic and new modality compounds across multiple US locations in a hybrid format.
What they're looking for
- Bachelor's degree in biological, pharmaceutical, chemical, or engineering sciences; advanced degree preferred
- Minimum 4 years pharmaceutical or healthcare industry experience including post-graduate education
- Solid understanding of biology, chemistry, and/or engineering relevant to pharmaceuticals
- Prior experience in drug development, analytical development, or manufacturing
- Experience interacting with Health Authorities independently or under CMC RA supervision
- Working knowledge of global Health Authority regulations and guidance
What you'll be doing
- Develop and execute global CMC regulatory strategies and dossier plans based on scientific and risk-based principles
- Lead CMC teams and provide regulatory expertise on core and global regulatory teams to support product development
- Prepare and support regulatory dossier submissions to Health Authorities for development and marketed compounds
- Coordinate and manage country-specific CMC documentation required for global regulatory approvals
- Escalate regulatory compliance issues affecting product registration and lifecycle management to senior management
Privacy & handoff
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