- BeOne Medicines (San Mateo, CA)
- …taken when recalls or product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for clinical protocols and ... regulatory strategies as well as authoring CTD CMC sections for the assigned project to...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- Regeneron Pharmaceuticals (Troy, NY)
- …of responses to regulatory agency inquiries. + Act as the project manager related to program submission strategies, including timelines, approach, and ... We are seeking a highly motivated and experienced Senior CMC Regulatory Sciences Specialist (Commercial Submissions) to...may be for you if you have: + Strong project management and communication skills. + Ability to work… 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. ... mapping resource across projects. In this role, the Senior CMC Project Manager is the...With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address… more
- Sanofi Group (Morristown, NJ)
- …the world. **Main Responsibilities:** The CMC Manager , develops the regulatory CMC strategy for the project (s)/product(s) assigned. This involves: + ... sets-up corrective action plan and/or proposes alternate solutions. + Regulatory CMC Manager / PFP...dates. + Providing timelines for critical CMC regulatory activities to be incorporated into the project… more
- Cardinal Health (Dover, DE)
- …systems and contributes to reports and presentations for clients. May serve as a project manager for smaller projects and ensure that team members achieve ... hands-on guidance of experienced Scientists, learns variety of internal, client, and regulatory systems and develop authoring and project management skills… more
- Lilly (Lebanon, IN)
- …a 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...from portfolio entry to global submissions/approvals and launch. The Project Manager is expected to have commercial… more
- Teva Pharmaceuticals (West Chester, PA)
- Manager , Regulatory Affairs Date: Jun 3, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: 61795 **Who we ... spend your day** Teva Pharmaceuticals USA Inc. seeks a Regulatory Affairs Manager in our West Chester,...Authority Applications (directly or indirectly) + Authoring and Reviewing CMC content for use in Health Authority Applications +… more
- Fresenius Medical Center (Knoxville, TN)
- …to comply with regulatory requirements + Organization of submission-readiness of regulatory documentation (eg, CMC relevant parts) + Organize and support ... + Supporting the department in cross-site activities to monitor product quality and regulatory compliance The internal Job Title is called **Global Product Center … more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- …of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external...needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,… more
- Merck (Rahway, NJ)
- …and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS ... Areas, Portfolio Management, Process Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance,… more
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