- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the ... supervision. Acts as point of contact to cross-functional teams on US/EU RA CMC project issues.Execution of Strategy and Submissions: Develops strategy with… more
- Genmab (Plainsboro, NJ)
- …are not limited to, medical, statistics, programming, trial management, data management, regulatory , nonclinical, CMC , and project management. The successful ... developing, and writing clinical documents to support medical and regulatory activities across the Genmab portfolio by ensuring that...a position where you will be involved in strategic project , as well as trial-related activities, and will have… more
- Sanofi Group (Bridgewater, NJ)
- …( CMC ) Team as a Manager and you'll develop the Global Regulatory CMC strategies for development and marketed products within Global Regulatory ... **Job title:** Manager , Regulatory Affairs CMC ...**Job title:** Manager , Regulatory Affairs CMC - Vaccine +...other parts of GRA + Provide Regulatory CMC leadership, guidance, and coordination to project … more
- Takeda Pharmaceuticals (Trenton, NJ)
- …**Job Description** **About the role:** We are seeking a highly motivated and qualified regulatory CMC professional for the Global Regulatory Affairs CMC ... CMC & Device organization is responsible for global CMC regulatory strategies and activities for the...the communication and flow of regulatory information ( regulatory framework, scope and project timelines) to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the ... point of contact to cross-functional teams on US/EU RA CMC project issues. + **Execution of Strategy...Leads US FDA/EU EMA interactions with support from higher-level manager . + ** Regulatory Knowledge:** Demonstrates expert knowledge… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- Regeneron is seeking a Manager to join the Regulatory Intelligence Group! **In this role, a typical day might include:** The Regulatory Intelligence ... from assigned departments or functions within the organization's GxP framework. The Regulatory Intelligence Manager will also facilitate processes to hold… more
- System One (Warren, NJ)
- Job Title: Technical Transfer Project Manager Location: Warren, NJ/ Seattle, WA Hours/Schedule: Mon- Fri business hours Compensation: $73.00- $83.91 Type: ... Contract Overview Leading Pharmaceutical company looking for an experienced Technical Transfer Project Manager . Ideal candidates should have 5+ years experience… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …optimization, and supervision of other manufacturing activities at CMOs. + Work within the CMC group and with internal and external project teams for timely ... and respect in all we do, create and deliver. As part of the CMC (Chemistry, Manufacturing and Controls) team of ITCI, **the** **Senior Manager , Formulation… more
- Integra LifeSciences (Plainsboro, NJ)
- …what's possible and making headway to help improve outcomes. This **Senior Manager , Quality Operations** will manage and provide oversight on Quality Compliance for ... change control projects and daily operations which may include leading project teams focused on key initiatives including quality process improvements, process… more
- Taiho Oncology (Princeton, NJ)
- …and support RFI and RFP processes, including bid comparison, analysis, negotiation, and project award. + Ensures compliance with all regulatory and reporting ... Sr. Manager , Outsourcing & Vendor Management Princeton, NJ, USA...Lab, IRT, IRBs, Wearables, Investigators sites, Medical Affairs, HEOR, CMC and other related ancillary providers etc.) sourcing experience… more
