- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global ... role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as... Affairs, as well as cross-functional stakeholders (eg, RA CMC , R&D Excellence, Clinical Operations, IT).Responsibilities Operate within and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …this role, a typical day might include the following:** + Responsible for CMC /CP product development activities to lead the regulatory standpoint during early ... for program-specific discussions, connect the dots across IOPS, proactively identify CMC /CP regulatory issues and develop appropriate strategies to mitigate… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs, is responsible for the development ... marketed products in US and Canada. In addition, the Senior Director, Commercial Regulatory Affairs, in collaboration...Commercial Regulatory Affairs, in collaboration with Head, Regulatory Affairs and CMC -RA, will review and… more
- Bristol Myers Squibb (Summit, NJ)
- …a member of a cross functional team responsible for drug product related CMC strategy development. **Key Responsibilities** The Senior Principal Scientist will ... and support the generation of appropriate responses to questions from regulatory authorities. **Key Responsibilities** The Senior Principal Scientist will… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. **Summary** The Regulatory Data Manager will be a key member of the Global ... As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as cross-functional stakeholders (eg,… 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 ... The **Sr Manager , Clinical Drug Supply & Logistics** is responsible...within budget and with good quality, in compliance with Regulatory Authorities' regulations / guidelines and Regeneron SOPs /… more
- Merck (Rahway, NJ)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas) ... **Job Description** The drug development Project Manager is part of Global Project and Alliance...+ Providing mentoring, coaching, and oversight to Specialist and Senior Specialist project managers working on common projects. Sharing… more
