- AbbVie (North Chicago, IL)
- …Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with internal and external partners to deliver products to ... apply and further develop regulatory and technical expertise in small molecule CMC development of peptides and sterile injectables. This individual prepares CMC… 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 ICH ... knowledge, and company policies and procedures. + Develops and implement CMC regulatory strategies, guiding teams across product lifecycle stages. + Actively… more
- United Therapeutics (Research Triangle Park, NC)
- …not currently an option. **Who You Are** Do you have extensive, highly technical CMC knowledge? If you're passionate about getting novel treatments into the hands of ... and lead the preparation, compilation, and review of regulatory submissions and related CMC and labeling documents pertaining to US, EU, and ROW for assigned… more
- BeOne Medicines (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics....the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD … more
- Sanofi Group (Framingham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA Waltham, MA **About the Job** Are you ready to shape the future of medicine? The race ... critical in helping our teams accelerate progress. As GRA CMC lead within our team, you'll have the opportunity...to improve people's lives. The Global Regulatory Affairs (GRA) CMC & Device Organization within Sanofi R&D serves as… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Program Manager, CMC Dossier Management assists with the development and oversight of Chemistry, ... Manufacturing, and Controls ( CMC ) strategic project plans to support CMC regulatory deliverables such as INDs/IMPDs and Marketing Applications. Regulatory… more
- AbbVie (North Chicago, IL)
- …third parties. The primary function is to ensure consistent preparation of CMC regulatory submission documents of high scientific and technical quality that are ... efficient processes for preparation, review and approval of these CMC sections. Plays a critical role in ensuring that...sections. Plays a critical role in ensuring that the CMC submission strategy is aligned closely with the clinical/regulatory… more
- Sanofi Group (Framingham, MA)
- **Job Title:** CMC Project Lead, Synthetics **Location:** Framingham, MA, Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The race is ... in helping our teams accelerate progress. As part of Global CMC Project Management group within R&D CMC Development, the CMC Project Leader is responsible to… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** GRA CMC Lead, Vaccines **Location:** Swiftwater, PA/ Morristown, NJ/ Framingham, MA **About the Job** Are you ready to shape the future of medicine? ... Ready to get started? **Main Responsibilities:** + Develop global regulatory CMC strategies and risk assessments for development projects and/or marketed products… more
- Lilly (Indianapolis, IN)
- …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 patients who ... Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC... CMC commercial solid oral products will use CMC technical knowledge and regulatory science expertise to drive… more
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