- Unknown (Boston, MA)
- …will be responsible for all aspects of regulatory affairs, including global strategy, CMC , operations, and management of regulatory vendors. They will also be the ... knowledge of FDA, EMA, and ICH guidelines, and strong project management skills. The role demands an individual with...work effectively with cross-functional teams are also essential. Hiring Manager Title President, Co-Founder & Head of R&D Travel… more
- Sanofi Group (Framingham, MA)
- **Job Title:** CMC Project Manager **Location:** Framingham, MA **About the Job** Join the engine of Sanofi's mission - where deep immunoscience meets bold, ... R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. The CMC Project Manager is a key contributor of the CMC … more
- Parexel (Augusta, ME)
- …options to patients. We are currently seeking a dedicated and detail-oriented **Regulatory CMC Project Manager ** to join a growing, dedicated client ... regulatory requirements. Project Management: Serve as the project manager for meetings, adhering to best...3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls). + Strong project… more
- ICON Clinical Research (San Antonio, TX)
- …we welcome you to join us on our mission to shape the future of clinical development. ** CMC Project Manager I- San Antonio Tx- Hybrid** ICON is looking for a ... CMC Project Manager I to join our Accelerated Pharmaceutical Solutions department located in San Antonio, TX. In this role the project manager will… 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). + ... the role** Join us as our **Global Manufacturing Sciences CMC Lead** and drive **high-impact, high-visibility CMC ...Sciences CMC Lead** and drive **high-impact, high-visibility CMC projects for innovative biologics in a dynamic global… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …standards. Lead responses to Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and provides expert interpretation ... of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality,… more
- BeOne Medicines (Emeryville, CA)
- …implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global ... product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- WuXi AppTec (Austin, TX)
- **Overview** The AD Project Manager will be responsible for managing projects within STA, WuXi's API, and Drug Product development and manufacturing division. ... Leads the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team, and business development… more
- Lilly (Philadelphia, PA)
- …to make life better for people around the world. **Position Overview:** The Manager , CMC Operations is responsible for independently managing technical transfer ... and/or presentations to internal team leaders for visibility into project progress and adherence to overall project ...transfer documents for Lilly and CMOs + Support the CMC team in ensuring that internal and external manufacturing… more
- Bristol Myers Squibb (Indianapolis, IN)
- …critical to advancing our preclinical development, Chemistry, Manufacturing, and Controls ( CMC ) strategy and ensuring successful technology transfer to clinical and ... experiments for pre-clinical development of radiopharmaceuticals. . Drive and support CMC process development and optimization for clinical drug products, including… more
