- 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
- Genentech (South San Francisco, CA)
- **The Position** **Technical Development Team Project Manager ** The Technical Development Team Project Manager (TDT PM) partners with a Technical ... **preferred.** Preferred Knowledge/Skills/Competencies + Understanding of the drug development and CMC process development. + Project management experience with… 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
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …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
- Kelly Services (Malvern, PA)
- …other cross-functional departments + Participate in and/or lead cross-functional meetings with CMC and project team representatives and stakeholders + Lead ... ** Project Coordinator** Kelly Services is currently seeking a...of Kelly Services, Inc., is currently seeking a Content Manager for a 12 month + engagement at one… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …not limited to healthcare antiseptic products. Under the mentorship of the Sr. RA Manager of Regulatory Affairs, they are responsible for the development of ... the regulatory requirements and support the proposed product claims. + Review CMC changes and determine regulatory reporting category in accordance with FDA… more
- Boehringer Ingelheim (Duluth, GA)
- …stakeholders will vary from USA GI Region, USA CMC , Corporate Affairs or regulatory agencies. + In partnership with RA project team members, helps drives ... initiatives to achieve USA priorities for RA and USA CMC objectives. This role is directly responsible for improving...and responsible for supporting RA leader by reflecting the regulatory submission timing needed for project program.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …or more products and provide strong technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products. ... and timely decision-making. + Represent Biologics Product Sciences on cross-functional CMC and project teams and collaborate closely with Pharmaceutical… more
- ThermoFisher Scientific (Greenville, NC)
- …+ Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing ... of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. +… more
- ThermoFisher Scientific (Greenville, NC)
- …+ Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing ... depend on - now and in the future. Our Project Delivery colleagues within our PPD(R) clinical research services...global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC… more
- Teva Pharmaceuticals (Weston, FL)
- …affect program delivery or quality. Work with all key departments-clinical, commercial, regulatory , CMC , operations, IP, TPO-to ensure program quality and ... Senior Manager R&D Global Program Leadership Date: Nov 13,...also manages resource allocation, documentation, and the application of project management tools as required. Travel Requirements: Willingness and… more
- ThermoFisher Scientific (Wilmington, NC)
- …consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, ... members involved in the study set up (DM, Reg, CMC etc ): ensure feasibility report are exhaustive, Review...activity timelines and metrics, providing status updates to the project manager , regularly reviewing projects using tracking… more
- AbbVie (Barceloneta, PR)
- …program execution strategies with clearly defined deliverables and milestones. The program manager is to kick-off project /transfer teams, remove barriers to ... with experience in drug substance and/or drug product transfers. The program manager is to provide strategic oversight for one or more industrialization programs,… more
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