- Kelly Services (Winston Salem, NC)
- **Job Title: Manager , Regulatory CMC (Contractor)** **Hourly Pay Rate: $62.50** **Schedule: Monday-Friday, 9:00 AM-5:00 PM (Must work Eastern Time hours)** ... **Position Summary:** An advanced therapy biotech organization is seeking a ** Manager , Regulatory CMC (Contractor)** to provide specialized support for… more
- AbbVie (Waltham, MA)
- …Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with ... internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content… more
- Gilead Sciences, Inc. (Foster City, CA)
- …knowledge, with manager support. + Invests in acquiring knowledge about CMC regulatory intelligence including guidelines and regulatory trends. **Basic ... This exciting role of Regulatory Affairs Associate II, CMC sits in Gilead's CMC Regulatory Affairs - Small Molecule Group. Responsibilities and… 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. ... the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Manager , CMC Development and Dossiers **Location** : Morristown, NJ **About the Job** The Manager , CMC Development and Dossiers is ... content generation for reports leading to the authoring of CMC dossier content for regulatory submissions and...the authoring of CMC dossier content for regulatory submissions and quality documentation. This is conducted ensuring… more
- Deloitte (Stamford, CT)
- …(ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA/EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years ... equitable future of health. Work You'll Do As a Manager you will lead and deliver engagements, or components...+ 4+ years Life Sciences Chemistry, Manufacturing, and Controls ( CMC ) experience to include: + Introducing new technologies like… more
- Charles River Laboratories (Rockville, MD)
- …build a career that you can feel passionate about. **Job Summary** The Senior CMC Project Manager leads project execution after deal closure. Responsible for ... mapping resource across projects. In this role, the Senior CMC Project Manager is the key interface...With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address… more
- Abeona (Cleveland, OH)
- …commercialization and capacity expansion objectives. + Collaborate with Clinical Operations, Regulatory , Medical Affairs, CMC , Biometrics, and other functional ... We are seeking a highly skilled and driven Senior Manager of Project Management to lead and drive strategic...working with technical operations or similar groups and has CMC experience within the pharmaceutical or biotech industry. The… more
- University of Michigan (Brighton, MI)
- Medical Assistant Senior ( CMC ) - Brighton Center for Specialty Care Apply Now **Mission Statement** Michigan Medicine improves the health of patients, populations, ... process and strives to meet budgetary expectations. Actively participates in regulatory compliance activities. + Coordinates use of exam/procedure room space.… more
- AbbVie (North Chicago, IL)
- …Chemistry, Process Engineering, Drug Product Development (DPD), and Quality Assurance (QA) and CMC - Regulatory . Responsibilities: + Manager a small team (3 ... R&D) is a global analytical scientific organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products.… more
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