- Parexel (Frankfort, KY)
- …innovative treatment options to patients. We are currently seeking a dedicated and detail-oriented ** Regulatory CMC Project Manager ** to join a growing, ... requirements. Project Management: Serve as the project manager for meetings, adhering to best...Project Management). + 3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing,… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, ... domestic/international travel. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications… more
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** **Title: CMC Project Manager ** **Location: Cambridge, MA (Hybrid)** **About the ... role:** As a CMC Project Manager , you will...& discontinuation, launch execution & global expansion/contraction, COGs management, regulatory activities, product / process. + knowledge, capability &… more
- 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
- Merck (Jackson, MS)
- …Informatica Metadata Manager , Management Process, Process Flow Documentation, Project Management, Regulatory Documents, SAP Master Data Governance (MDG), ... development through commercialization, with practical insight into how these operations generate CMC regulatory content + Understanding of CMC operations,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior Manager ... in the design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an innovative and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …approaches to reduce COGs and strengthen supply reliability. + Collaborate closely with an assigned CMC Project Manager (who will provide you PM support). + ... Site Manufacturing Sciences, QA, QC, Engineering, Supply Chain, Validation and Regulatory CMC to ensure aligned, efficient CMC execution across functions… more
- Teva Pharmaceuticals (West Chester, PA)
- CMC Biologics Quality Control Director, Physiochemical Testing Date: Nov 15, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... and stability testing, raw materials testing, contract lab testing, and regulatory submissions. The incumbent may also participate in/provide oversight of activities… more
- Actalent (Lake Forest, CA)
- Description We are seeking an experienced and strategic Regulatory Affairs Manager to support global regulatory submissions and compliance activities. This ... of global medical device regulations (eg, FDA CFR, EU MDR). Skills Regulatory , new product development, quality, 510(k), Project management, engineering, MDR,… more
- CSL Behring (King Of Prussia, PA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . + Proactively fosters and promotes effective relationships ... Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure 'One GRA Voice', appropriate...(eg, GRAST, GRL & Commercial) on means to address project challenges, leverage regulatory opportunities and advise… more