- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall CMC ... based on the project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …(including participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS- CMC Associate Director , Biologics will serve as the ... Sciences (GRS) and Global Product and Supply (GPS). The GRS- CMC Associate Director , Biologics will...of global change management. **Position Responsibilities** + Represent regulatory CMC on and/or lead matrix teams for… more
- Bristol Myers Squibb (Summit, NJ)
- …careers.bms.com/working-with-us . **Position Summary** Bristol Myers Squibb is seeking an Associate Director , Principal Product Leader within the Cell Therapy ... The Principal PQL will support the Global Product Quality Lead (PQL) by providing supportive quality oversight of the...+ May act as author or Quality reviewer of CMC sections of regulatory submissions and response to global… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the manufacturing ... (mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing ... serve as G-RACMC lead or regional submission lead . Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other functional teams… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Device Regulatory Lead ( Associate Director )** + Location: Bridgewater, NJ or Swiftwater, PA or Cambridge, MA **About the job** The Global ... team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global R&D. This critical...get started? **Main responsibilities** + Serve as Device Regulatory Lead on assigned project teams (early phase, late stage… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Associate Director , Business Development will seek out potential business opportunities ... efficiently communicating with excellent facilitation. The incumbent will also lead initial partnership, licensing and/or acquisition negotiations with sufficient… more
- Bristol Myers Squibb (Summit, NJ)
- …or more areas (ie, research, analytical, quality, engineering, manufacturing, regulatory CMC , or IT). + Proven ability to understand complex processes/problems and ... through various formats (eg presentations, written proposals, reports, correspondence, lead meetings, face-to-face dialogue, etc.) + Proficiency in data analytics… more
- ManpowerGroup (Rahway, NJ)
- …and providing CVM/FDA support for labeling and chemistry, manufacturing, and controls ( CMC ) submissions. + The specialist position also works as part of a ... compendium; obtains US Free Sales Certificates. + The specialist may lead /support teams on various regulatory topics; optimize procedures, processes, and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …as staff from quality, clinical compliance, regulatory, formulations, and IOPS ( CMC , external manufacturing, stability). **A typical day might include the ... following:** + Serves as lead drug supply manager of a program and/or individual...and delivery to investigator sites. Works with Clinical Logistics Associate to complete this activity and/or handles any/all aspects… more