- Bristol Myers Squibb (New Brunswick, NJ)
- …Information to build/maintain database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is ... a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key...HA meetings); and/or post-approval submissions. In this role, the GRS- CMC Associate Director , Biologics will… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …project development preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for ... areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall ...CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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
- Sanofi Group (Bridgewater, NJ)
- **Job title: Device Regulatory Lead ( Associate Director )**...of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and ... PA or Cambridge, MA **About the job** The Global Regulatory Affairs Device team is a globally diverse team...territories that need "new" thinking and approaches from a regulatory perspective. You will be expected to proactively initiate… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …New Modality) team. - Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses ... (mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …professionally to achieve your own career goals. **Job** **Title:** Scientific Associate Director **Location:** New Brunswick **Division:** Global Production & ... at all microbiological testing locations in the BMS network. The Scientific Associate Director will also ensure appropriate strategies for DP-related… more
- Merck (Rahway, NJ)
- …across CMC development and commercialization, Quality Assurance, Technical Operations, and CMC Regulatory Affairs as needed to ensure understanding of needs, ... and clinical development pipeline of new small molecule products. The Executive Director reports directly to the Associate Vice President, Small Molecule… more
- Merck (Rahway, NJ)
- …the Research & Division organization of our company. **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core member of Early ... progress the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and… more
- Merck (Rahway, NJ)
- …insights in structure-function and molecular interactions with excipients. The Executive Director reports to the Associate Vice President, Analytical Enabling ... **Job Description** The Executive Director of Structure Characterization & Elucidation is responsible for providing strategic and technical leadership to enable deep… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …managers, medical monitors, as well as staff from quality, clinical compliance, regulatory , formulations, and IOPS ( CMC , external manufacturing, stability). **A ... teams of pending IP expiry. + Coordinates with other functional areas, including Regulatory , Medical Director , Forecasting & Planning, and IOPS to define… more