- Regeneron Pharmaceuticals (Troy, NY)
- We are seeking a highly motivated and experienced Senior CMC Regulatory Sciences Specialist (Commercial Submissions) to join our dynamic CMC ... writing skills are essential for effectively communicating complex scientific information. As a Senior CMC Regulatory Sciences Specialist, a typical day… 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
- 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
- Vera Therapeutics (Brisbane, CA)
- …development programs. The Senior Manager will support both Clinical Regulatory and CMC activities. Responsibilities: * Proactively manage regulatory ... Title: Senior Manager , Clinical Regulatory Location: Brisbane, California About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology… 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
- Bausch Health (Bridgewater, NJ)
- …aspects of product development team for agency filing + Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain all product ... itwhere your skills and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory … more
- AbbVie (Worcester, MA)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager of Program Management will lead the Manufacturing ... AbbVie's pipeline and our External Contract Manufacturing business partners. The Senior Manager provides project management leadership to ensure successful… more
- Bristol Myers Squibb (Summit, NJ)
- …pipeline cell therapies enabling global regulatory approval and launches. The Senior Manager , Portfolio Planning and Execution plays an important role in ... to support Hoshin Kanri planning and CTDO portfolio. The Senior Manager , Portfolio Planning and Execution manages...PMP certification highly desirable. + Understanding of cGMPs and regulatory CMC . + A minimum of 8… more
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