- WuXi AppTec (Plainsboro, NJ)
- …STA Pharmaceutical, a WuXi AppTec Company, has an exciting opportunity for a ** Manager /Senior Manager , CMC Project Management.** This position ... lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team, and business development… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …requirements for CMC and GMP related submissions and inquiries. + Represents CMC RA in project team meetings and provides regulatory guidance and perspective ... Provide CMC regulatory strategy input and expertise in the...marketed biologic and small molecule drug products to assigned project teams, to ensure Otsuka's products are developed/maintained in… more
- Sanofi Group (Morristown, NJ)
- …with other parts of GRA. + Provide leadership, guidance, and coordination to project teams of GRA CMC professionals in delivering specific development and ... **Job Title:** Regulatory Affairs Manager **Location:** Swiftwater, PA, Morristown, NJ **About the...CMC issues. Articulate the implication of issue to project team risk/benefit strategic component. + Assures that positive… 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 ... 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 of US/EU… more
- Sumitomo Pharma (Trenton, NJ)
- …a dynamic, highly motivated, and experienced individual for the position of **Senior Manager , Clinical Supply Chain** . The Senior Manager , Clinical Supply Chain ... supplies on multiple clinical programs. In addition, working closely with CMC , Regulatory Affairs, Quality Assurance, Clinical Operations, and /or SMPA external… more
- Merck (Rahway, NJ)
- …of the Executive Director, GPAM, the core responsibility of this Value and Implementation Project Manager role will be direct management of Project Managers, ... Managers supporting Value & Implementation (which is this job), Development, and CMC ; Discovery Portfolio Managers; Alliance Managers; Project Management Office… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …and drive business strategy using advanced data science and analytics. The Senior Manager , Development to Launch Analytics will join a dynamic and collaborative data ... to proactively identify and address priority business questions related to CMC development, new product introduction and business operations. This includes all… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …the care of patients with life-threatening diseases. The **Sr. Clinical Supply Manager ** is a leader that inspires teams while providing expertise for Gilead's ... Pharmaceutical Development and Manufacturing Teams to develop strategies, meet project deliverables, solve business problems. The position includes all elements… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works ... the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works… more
- Sumitomo Pharma (Trenton, NJ)
- …**Job Overview** We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in clinical pharmacology, ... closely with program management, clinical development, PV, Biostat/Data Management, CMC , Biomarker/Translational Research, preclinical DMPK, etc to formulate clinical… more