- 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
- Lilly (Lebanon, IN)
- …successful startup into GMP manufacturing operations. **Position Description:** The CMC Project Management Professional is responsible for overseeing the Chemistry, ... Manufacturing, and Controls ( CMC ) activities for our pharmaceutical products. This role requires...portfolio entry to global submissions/approvals and launch. The Project Manager is expected to have commercial product manufacturing knowledge,… more
- Merck (Rahway, NJ)
- …within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Manager , Supply Chain leads, develops, establishes, and manages the ... working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs, Marketing, Market Access, Medical Affairs, Drug Safety, Finance,… more
- ThermoFisher Scientific (Wilmington, NC)
- …of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. + ... show the above in your submittal to be considered)** ** Senior Director Project Mgmt - Oversight** At Thermo Fisher...in the Con Mod process. + Communicates with People Manager (s) to support the development of the employee providing… 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
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