- Organon & Co. (Jersey City, NJ)
- …regulatory strategies. + Prepare and review information required for development of regulatory CMC dossiers for commercial products. + Provide input to global ... milestones for assigned products across the product lifecycle. Identify and communicate potential regulatory issues to Organon Regulatory CMC management, as… more
- Organon & Co. (Jersey City, NJ)
- …to the Executive Director in Organon's Regulatory Chemistry, Manufacturing and Controls ( CMC ) New Products, the Senior Scientist is responsible for ... products including biosimilars in accordance with global regulations, guidances and defined regulatory strategies. The Senior Scientist is responsible for… more
- Bristol Myers Squibb (Summit, NJ)
- …professionally to achieve your own career goals. **Position Summary:** The Senior Principal Scientist will be an CMC analytical lead ( CMC -AL) for drug ... of analytical scientists, and a core member on the CMC team. The Senior Principal Scientist...product. + Understands drug development and works to build CMC dossier for regulatory submissions as an… more
- Bristol Myers Squibb (Summit, NJ)
- …for drug product related CMC strategy development. **Key Responsibilities** The Senior Principal Scientist will collaborate across BMS sites with Analytical, ... questions from regulatory authorities. **Key Responsibilities** The Senior Principal Scientist will collaborate across BMS...and process development principles. + Experienced in building the CMC dossier for regulatory submissions as an… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …**Summary** The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more