- AbbVie (North Chicago, IL)
- …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 ... CMC function (chemistry, analytical, formulation, etc.) in order to assist CMC project teams in the planning, preparation, review and approval of… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Senior Manager , Global Regulatory Affairs, CMC Small Molecules where you ... CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …innovation-driven 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 of Statistics, you will provide statistical leadership in...design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an… more
- BeOne Medicines (San Mateo, 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 ... throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development...product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for… more
- Danaher Corporation (Fargo, ND)
- …track project metrics, forecast capacity, and provide regular updates to senior leadership on project status, risks, and opportunities. + Support Business ... This position reports to the Director of Drug Product CMC and is part of the Drug Product Program...years of experience in a client-facing role as a project , program, or account manager within the… more
- CSL Behring (King Of Prussia, PA)
- …developing therapies that make a meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, Hematology ? The job is in our ... and create greater impact for patients. With a streamlined, project -led structure and a focus on collaboration, we're building...Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure 'One GRA Voice', appropriate… more
- CSL Behring (Waltham, MA)
- …developing therapies that make a meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, Vaccines? The job is in our ... lead discussion at Global Regulatory Forum (GRF) or with senior management on projects. *Lead GRA project ...relationships with GRAST members, including GRAS Regions and Regulatory CMC . *Applies the CSL Leadership Capabilities - Build Bridges,… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Senior Scientist, MSAT **Location** : Framingham, MA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the ... from infectious diseases and bring hope to patients and their families. The Senior Scientist will be responsible for developing and executing bioassays for various… more
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- …associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works ... the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Director, Product Management Team Lead (Early Phase) will have experience serving as project manager for early phase biopharma molecules and will serve as a ... 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director,** **Product Management** **Team** **Lead** **(Early Phase)** **_Location:… more
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