Organon Senior Scientist, Regulatory CMC (Multiple Openings)
Job title: Organon Senior Scientist, Regulatory CMC (Multiple Openings) Company: Merck Job description : Job Description nPosition Description: nReporting to the Director or Executive Director in our company’s Regulatory CMC, the Sr. Scientist is responsible for implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule or biological products in accordance with global regulations, guidance’s and defined regulatory strategies. The Senior Scientist is responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products. nRegulatory CMC Responsibilities: nProvide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks. nExecute regulatory strategies by leading the development, auth...