Senior Scientist, Product Lead CMC Regulatory Affairs
Job in
Jersey City, Hudson County, New Jersey, 07390, USA
Listed on 2026-10-09
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-09
Job specializations:
-
Pharmaceutical
-
Healthcare
Job Description & How to Apply Below
Senior Scientist, Product Lead in CMC Regulatory Affairs for Synthetics and New Modalities at Johnson & Johnson's Innovative Medicine division.
Responsibilities- develop and execute global CMC regulatory strategies
- contribute to regulatory dossier preparations
- support filings for development and marketed products
- collaborate on global regulatory and cross-functional teams
- Provide regulatory expertise on CMC topics
- lead regulatory submissions
- manage country-specific documentation
- support health authority inspections
- Drive continuous improvement and ensure regulatory compliance aligned with global strategies and therapeutic area needs
- Bachelor's in Biological, Pharmaceutical, Chemical, or Engineering Sciences
- 4+ years in pharmaceutical or healthcare industry
- experience in drug development, analytical development, or manufacturing
- Knowledge of global health authority regulations
- Strong communication skills
- Ability to defend regulatory strategies
- advanced degrees (Master's, PharmD, Ph.D.)
- experience working with health authorities independently
Focus on small molecules or biologics in development stages, supporting global filings, with emphasis on regulatory strategy for innovative modalities.
Work setuphybrid, based in Titusville, NJ;
Raritan, NJ;
Spring House, PA; or Horsham, PA.
Position Requirements
10+ Years
work experience
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