- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …generation, design and leadership of clinical development plans, and addressing all regulatory , drug and patient safety, data, CMC , IP, patient selection, ... the engine of development is the cross functional, empowered and agile Global Project Team (GPT), directly accountable to global Development governance. In this key… more
- System One (Warren, NJ)
- Job Title: Regulatory Project Manager CMC Location: Warren NJ (Hybrid) Compensation: $80 W2 Type: Contract Responsibilities Primary Responsibilities: + ... analytical development, quality, and regulatory , to support project objectives. + Develop and maintain detailed CMC... project objectives. + Develop and maintain detailed CMC project plans, including resource allocation, risk… more
- Sanofi Group (Bridgewater, NJ)
- **Job title:** Manager , Global Regulatory Affairs CMC + Location: Bridgewater, NJ **About the job:** The Manager , Global Regulatory Affairs CMC ... Products, Biologics, and Vaccines). This individual is responsible for global regulatory CMC strategies, submission dossiers and approvals, including direct… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Manager Regulatory Affairs Date: Jun 14, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 56073 **Who we are** ... activities on assigned projects and ensure that the project deadlines and performance standards for these projects are...User Fee Act (GDUFA)/ Prescription User Fee ACT (PDUFA), CMC and regulatory filing aspects; Drafting correspondences… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …the Senior Director, Commercial Regulatory Affairs, in collaboration with Head, Regulatory Affairs and CMC -RA, will review and assess all commercial ... and creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs, is responsible for the development and execution of the post-approval… more
- Merck (Rahway, NJ)
- **Job Description** The drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division ... organization of our company. **Position Description/Summary:** The GPAM Associate Director, Project Manager , is a core member of Early Drug Development and/or… more
