- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... Leads US FDA/EU EMA interactions with support from higher-level manager . + ** Regulatory Knowledge:** Demonstrates expert knowledge...experience and 4+ years direct or related CMC regulatory experience + Successful track record… 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