- WuXi AppTec (Plainsboro, NJ)
- …STA Pharmaceutical, a WuXi AppTec Company, has an exciting opportunity for a ** Manager / Senior Manager , CMC Project Management.** This position ... will be responsible for managing DS and DP projects within STA. The position will lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team, and business development team. The… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team ... (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type… more
- Sumitomo Pharma (Trenton, NJ)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Senior Manager , Clinical Supply Chain** . The Senior ... supplies on multiple clinical programs. In addition, working closely with CMC , Regulatory Affairs, Quality Assurance, Clinical Operations, and /or SMPA external… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …questions and drive business strategy using advanced data science and analytics. The Senior Manager , Development to Launch Analytics will join a dynamic and ... that drive our enterprise forward. Reporting directly to the Associate Director or Senior Director, Development to Launch Analytics, you will play a pivotal role in… more
- Sumitomo Pharma (Trenton, NJ)
- …. **Job Overview** We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in ... of drug metabolism and bioanalytic chemistry. This position will report to Senior Director of Clinical Pharmacology and Drug Metabolism. S/he will work across… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory ... plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs… more
- BeOne Medicines (Pennington, NJ)
- Reporting to the Vice President, General Manager of US Manufacturing, Hopewell, NJ., this position plays a leading role in driving process robustness, technology ... process troubleshooting. This position involves close collaboration with the CMC , Process Development, Manufacturing, Quality Control, Quality Assurance and… more
- Bausch Health (Bridgewater, NJ)
- …development team for agency filing + Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain all product documentation is developed in ... your skills and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for… more
- Integra LifeSciences (Plainsboro, NJ)
- …through Sunday. **SUPERVISION RECEIVED** Under direct supervision of the Senior Manager , Manufacturing. **SUPERVISION EXERCISED** Directly supervises weekend ... Packaging Operations is responsible for the skin packaging production activities for CMC (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality… more