- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... experience and 4+ years direct or related CMC regulatory experience + Successful track record in preparation, management of review and approval of NDA/MAA/BLA… more
- 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)
- …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 (Summit, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Ti** **tle: Senior Director , CTTO External Manufacturing & Tech Transfer** **Location: ... developing process qualification, process control and comparability strategies, supporting major regulatory submission and contributing to the overall CMC and… more
- Bristol Myers Squibb (Summit, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Title:** Senior Director , Cell Therapy Technical Operations Tech Transfer ... here at BMS with our Cell Therapy team. The ** Senior Director , Cell Therapy Technical Operations Tech...strategies, supporting the authoring of technical sections of major regulatory documents and contributing to the overall CMC… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …and other global regulatory filings. **How you'll spend your day** The Senior Director : + Will foster relationships with opinion leaders in assigned ... Senior Director Clinical Development - Respiratory...working closely with other functional areas such as commercial, regulatory , pharmacovigilance, CMC , early clinical, and pre-clinical… more
- Bristol Myers Squibb (Summit, NJ)
- …lives while developing professionally to achieve your own career goals. **Title:** Senior Manager / Associate Director of Stability **Position Summary:** The ... art technologies to develop, enable and execute analytical and CMC strategies that ensure safety, quality and efficacy of...Stability Associate Director / Senior Manager is responsible for managing the stability programs… 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
- Merck (Rahway, NJ)
- …environment with key stakeholders across the organizations (MRL/MMD) such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of ... have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical, Clinical, and… 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …prioritization and strategy discussions with analytical leadership, Manufacturing Science &Technology, Regulatory , CMC , QC, Quality and the Bio Operations Unit. ... Work for Women in 2020, 2021 and 2022. **Position Summary** Reporting to the Director of Analytical Governance and Scientific Operations (AGSO), the AGSO Senior … more