- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. As a Senior Director of Quality Assurance CMC , you will be responsible ... activities related to the resolution of requests from the regulatory agencies. + Function as the CMC ...ability to inspire and motivate direct reports at the director level and below. + Ability to work independently… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …diseases, researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Development, may be called ... plans to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs -...support marketing product claims. + Acts as liaison between Regulatory Affairs & CMC and other functional… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Organon & Co. (Jersey City, NJ)
- …Description** **The Position** Reporting to the Executive Director in Organon's Regulatory Chemistry, Manufacturing and Controls ( CMC ) New Products, the ... for the preparation and review of information required for development of regulatory CMC dossiers for commercial products. Primary responsibilities include, but… more
- Bristol Myers Squibb (Madison, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Medical Director , US Lymphoma/CLL will report to the ... medical Lymphoma team supporting the MM/Lymphoma Disease Lead. The Senior Medical Director will provide key contribution...Research and Development + Statistics + Translational Research + Regulatory Affairs including CMC - Regulatory +… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …of Health audits for biologic or pharmaceutical production + Direct experience with writing CMC Drug Product sections of regulatory filings + Experience in a ... uses state-of-the art technologies to develop, enable and execute analytical and CMC strategies that ensure safety, quality and efficacy of life-saving medicines… more
- Merck (Rahway, NJ)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas) ... & Division organization of our company. **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core member of Early Drug Development… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …managers, medical monitors, as well as staff from quality, clinical compliance, regulatory , formulations, and IOPS ( CMC , external manufacturing, stability). **A ... Compiles and reports supply status to study teams and senior management + Applies knowledge of company policies and...IP expiry. + Coordinates with other functional areas, including Regulatory , Medical Director , Forecasting & Planning, and… more