- AbbVie (Waltham, MA)
- …(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 strategy… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the guidance of more senior staff, oversees the preparation of CMC regulatory submissions for investigational and commercial products with solid scientific ... exciting role of Regulatory Affairs Associate II, CMC sits in Gilead's CMC Regulatory...manager support. + Invests in acquiring knowledge about CMC regulatory intelligence including guidelines 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...throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development… more
- Charles River Laboratories (Rockville, MD)
- …help you build a career that you can feel passionate about. **Job Summary** The Senior CMC Project Manager leads project execution after deal closure. ... through mapping resource across projects. In this role, the Senior CMC Project Manager is...With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address… more
- Abeona (Cleveland, OH)
- Position Overview We are seeking a highly skilled and driven Senior Manager of Project Management to lead and drive strategic execution of multiple ... commercialization and capacity expansion objectives. + Collaborate with Clinical Operations, Regulatory , Medical Affairs, CMC , Biometrics, and other functional… 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, ... employer. **Job Detail** **Job Opening ID** 263624 **Working Title** Medical Assistant Senior ( CMC ) - Brighton Center for Specialty Care **Job Title**… more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …duties as required. **Additional Responsibilities, Knowledge, Skills and Abilities:** + Global Regulatory CMC Experience is preferred. + Ability to work ... to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting...team. **Additional Responsibilities, Knowledge, Skills and Abilities:** + Global Regulatory CMC Experience is preferred. + Ability… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …tools to promote engaged, collaborative, and results-driven work environments. _The Senior Manager , Verification Programs has the following responsibilities:_ * ... guideline on the Common Technical Document (CTD) for pharmaceuticals, and/or regulatory Chemistry, Manufacturing Controls ( CMC ) submission experience. * Detail… more
- BeOne Medicines (Pennington, NJ)
- Reporting to the Vice President, General Manager of US Manufacturing, Hopewell, NJ., this position plays a leading role in driving process robustness, technology ... and process troubleshooting. This position involves close collaboration with the CMC , Process Development, Manufacturing, Quality Control, Quality Assurance and … more
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