- BeOne Medicines (San Mateo, 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
- AbbVie (North Chicago, IL)
- …(https://www.tiktok.com/@abbvie) . Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with ... CMC development of peptides and sterile injectables. This individual prepares CMC regulatory strategies that enable first pass approvals. Develops and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …currently seeking an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located at ... activities within the project(s), in support of CMC development within EACD. The Associate Director /Senior Associate Director of EACD for drug… more
- AbbVie (North Chicago, IL)
- …external third parties. The primary function is to ensure consistent preparation of CMC regulatory submission documents of high scientific and technical quality ... strong negotiating, influencing, and leadership skills. + Manages completion of CMC regulatory submission documentation for multiple projects of moderate… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position ** Reporting to the Director in Organon Regulatory CMC , the Associate Principal Scientist is responsible for ... assigned products across the product lifecycle. + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC management, as… more
- Kelly Services (South San Francisco, CA)
- …rate:** $60-80/hour Be at the forefront of innovative small molecule drug development as the Associate Director of Project Management, CMC . You will play a ... innovation and operational excellence. You'll work closely with cross-functional leaders across CMC , Drug Development, QA, Regulatory , and external partners to… 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
- 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
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory data models, RIM systems (Veeva Vault preferred)** , and Regulatory processes (Labeling, CMC , Registrations). + Excellent analytical and ... the best of my knowledge. **Job Description** **Summary:** The Regulatory Data Governance Lead will ensure Regulatory ...The Regulatory Data Governance Lead will ensure Regulatory information and data standards are aligned with Takeda's… more
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