- Sanofi Group (Morristown, NJ)
- **Job Title:** Head of Global Regulatory Affairs , CMC Small Molecule **Location:** Morristown, NJ **About the job** Join the engine of Sanofi's mission - ... turn the impossible into possible for millions. **Our Team/ Overview:** The Global Regulatory Affairs (GRA) CMC & Device Organization serves as a critical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …operating seamlessly connected with the broader enterprise. + Partner with Regulatory Affairs , Quality, Technical Development, and Manufacturing stakeholders to ... roadmap that fosters innovation to assist where and when CMC RA invest resources and budget. + Own continuous...regulatory operations, strategic planning, and operational execution of CMC RA initiatives. + Experience with CMC … more
- CSL Behring (King Of Prussia, PA)
- …successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling ... connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . + Proactively fosters and promotes effective relationships… more
- Gilead Sciences, Inc. (Washington, DC)
- …health authorities and cross-industry associations. + Matrix/coordinate/lead strategy development with CMC Regulatory Affairs Policy Advisory and ... for Quality Policy issues in conjunction with the Gilead CMC Regulatory Policy Office. The role will...messaging. The role will report directly to the Global Head of Quality Policy and Advocacy **JOB DESCRIPTION** +… more
- Otsuka America Pharmaceutical Inc. (Waltham, MA)
- …but not limited to Translational Research & Biomarkers, Clinical Management, Global Regulatory Affairs , Global Clinical Development (late phase), Data & ... will serve as the Translational Medicine CNS Therapeutic Area Head , reporting to the VP, Translational Medicine and Early...Analytics, Early Commercial, Medical Affairs , Nonclinical Toxicology, Clinical Pharmacology, CMC , and… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …and Teva Standard Operating Procedures + Partners cross-functionally with departments such as Regulatory Affairs , CMC , Biostatistics, GCO, in the execution ... of the clinical development plan, working closely with Disease Area Head , Clinical Development Lead, Clinical Scientist. and other functional areas such… more
- ThermoFisher Scientific (Greenville, NC)
- …deliverables + Advanced, broad understanding of global/regional/national country requirements/ regulatory affairs procedures for clinical trial authorization, ... of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. +… more