- United Therapeutics (Research Triangle Park, NC)
- …regarding CMC regulatory issues and provide strategic CMC regulatory interpretation and guidance to project teams + Actively manage and mentor junior ... for assigned projects. This role will collaborate with the manager , project teams, and functional area representatives...and functional area representatives to devise and implement sound regulatory CMC and labeling strategies. + Manage… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as an Senior Manager , Global Regulatory Affairs, CMC Small Molecules where you will ... oversee the development and execution of regulatory CMC development and registration strategies. You...You will be RA CMC member on Regulatory , Pharmaceutical Development, and Production project teams… 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
- AbbVie (North Chicago, IL)
- …the development and oversight of Chemistry, Manufacturing, and Controls ( CMC ) strategic project plans to support CMC regulatory deliverables such as ... and tasks. Prioritize tasks with effective use of time. + Provide regular updates to CMC project team on progress of submission and after the content plan and… 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
- Cardinal Health (Washington, DC)
- …systems and contributes to reports and presentations for clients. May serve as a project manager for smaller projects and ensure that team members achieve ... **_What Chemistry, Manufacturing & Control ( CMC ) contributes to Cardinal Health_** The _Scientist I,...of experienced Scientists, learns variety of internal, client, and regulatory systems and develop authoring and project … more
- Adecco US, Inc. (Cambridge, MA)
- …of small-molecule oral dosage forms. + Proven track record as a ** project manager of technical projects** with multi-disciplinary, cross-functional teams. + ... submissions, and product control. + Support MSAT Program Directors and CMC Leaders by planning, coordinating, and tracking project activities, including:… more
- CSL Behring (King Of Prussia, PA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC .** **As assigned, supports development of CSL policy positions ... meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, Hematology ? The...**e.g.** **GRAST, GRL & Commercial) on means to address project challenges, leverage regulatory opportunities and advise… more
- CSL Behring (Waltham, MA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . *Applies the CSL Leadership Capabilities - Build Bridges, ... therapies that make a meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, Vaccines? The job is in our Waltham MA… more
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- …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
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