- Lilly (Philadelphia, PA)
- …to make life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory will leverage CMC technical knowledge ... and regulatory science expertise to drive global regulatory CMC strategies for Lilly | Avid diagnostic radiopharmaceutical products. This includes the… more
- BeOne Medicines (Emeryville, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **Essential Functions of the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the… more
- Atlantic Health System (Pompton Plains, NJ)
- …revision of procedures and documentation related to accreditation, adhering to all regulatory requirements for various authorities, including but not limited to CAP, ... medical laboratory technology/ medical or clinical laboratory science preferred + Associate 's degree in chemical, physical or biological science or medical… more
- Sumitomo Pharma (Lincoln, NE)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She...the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Associate Director , Global Regulatory Project Management (AD, Global RPM) is a strategic leader responsible for translating and ... executing regulatory strategies across the global drug development lifecycle. This...with senior stakeholders and cross-functional teams (clinical, medical, safety, CMC , commercial) across regions to achieve strategic business goals… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead ( Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The… more
- AbbVie (Irvine, CA)
- …+ Author and review CMC analytical sections of BLA and other CMC regulatory packages. Develop strategies for addressing health authority inquiries. + Provide ... supports manufacturing, process transfer/optimization/characterization/validation, analytical method transfer/optimization/validation, product characterization, regulatory submission, and continuous improvement for late-stage and commercial… more
- AbbVie (North Chicago, IL)
- …automation systems strategy and roadmap in alignment with department objectives and SM CMC R&D strategies. . Develop and revise project plans and budgets, work with ... . Provide guidance, technical advice, planning, and project management within SM CMC and with outside functions, consultants, and vendors. Support to laboratory… more
- Bristol Myers Squibb (Madison, NJ)
- …more: careers.bms.com/working-with-us . **Position Summary** Bristol-Myers Squibb is seeking an Associate Director , Principal Product Quality Leader (PQL), in ... of your application should be directed to Chat with Ripley. R1597688 : Associate Director , Principal Product Quality Lead **Company:** Bristol-Myers Squibb **Req… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **Title: Process Engineer Small Molecules API Process Science ( Associate Director )** **Location: Cambridge, MA (Hybrid)** **About the role:** ... As a Process Engineer Small Molecules API Process Science ( Associate Director ), you will provide process engineering...+ Other key functional groups such as Global Quality, Regulatory CMC etc. **Leadership** + Provide vision… more