- Lilly (Philadelphia, PA)
- …communities through philanthropy and volunteerism. **Position Overview:** The Manager, Manager- CMC Regulatory is responsible for the preparation and delivery ... of high-quality CMC regulatory submissions. This position supports Lilly/Avid diagnostic radiopharmaceutical marketed products globally. **Responsibilities:** +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of experience in digital or innovation roles preferred. + Strong understanding of CMC regulatory submissions and the structure/content of Module 3. + ... **1. Strategy and Roadmap Development** + Define and continuously refine a CMC RA Digital Enablement roadmap aligned to organizational priorities and enterprise… more
- 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)
- … CMC development of peptides and sterile injectables. This individual prepares CMC regulatory strategies that enable first pass approvals. Develops and ... FDA) regarding CMC matters. Scope of Responsibility: + Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with life-threatening illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project(s), in line with ... knowledge, and company policies and procedures. + Develops and implement CMC regulatory strategies, guiding teams across product lifecycle stages. + Actively… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop post approval and lifecycle regulatory strategies… more
- Lilly (Indianapolis, IN)
- … CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the ... development strategies and submission content + Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop post approval and lifecycle regulatory strategies… more
- Lilly (Indianapolis, IN)
- …that make life better for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and bringing life-changing new ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for clinical trials and marketing… more
- Takeda Pharmaceuticals (Boston, MA)
- …requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market ... and scientific rationale. + Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global… more
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