- Bristol Myers Squibb (Princeton, NJ)
- …documents to support Health Authority submissions. **Position Summary** The Global Regulatory CMC Operations & Policy Senior Director will manage a team ... they relate to GRS- CMC responsibilities. The Global Regulatory CMC Operations & Policy Senior Director will also be responsible for driving CMC … more
- Novo Nordisk (Princeton, NJ)
- …Are you ready to make a difference? The Position Reporting to the Senior /Executive Director or Vice President of Regulatory Affairs, the Director of ... on GMP compliance-related activities. May supervise others. Relationships Reports to the Senior /Executive Director or Vice President, Regulatory Affairs.… more
- 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
- 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
- Novo Nordisk (Plainsboro, NJ)
- …uniting the best of both worlds to develop new medicines for patients. The Position As Senior Medical Director for the liver disease team, you will be part of ... this role, the incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the… more
- Novo Nordisk (Plainsboro, NJ)
- …therapeutic area, help develop PRO and biomarker strategies. Relationships Reports to: Senior Medical Director Work with the Clinical Operations, Non-Clinical ... ready to make a difference? The Position The Medical Director serves as the subject matter expert for our...Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Outsourcing & Vendor Management Pleasanton, CA, USA * Princeton, NJ, USA Req #385 Friday, August 16, 2024 Looking for a chance to make a ... and expanding mid-size company in the role of Associate Director , Outsourcing and Vendor Management. Your expertise will play...Proposal (RFP) through contract execution for clinical studies and CMC projects as well as ongoing governance with key… more
- Integra LifeSciences (Plainsboro, NJ)
- … agencies. **SUPERVISION RECEIVED** Receives minimal supervision from the Director , CMC Quality Operations. **SUPERVISION EXERCISED** Manages personnel ... system requirements and how they impact product quality and regulatory compliance. + Works with Senior Management...quality and regulatory compliance. + Works with Senior Management to achieve alignment of Quality Goals and… more