- Catalent Pharma Solutions (Kansas City, MO)
- …+ Bachelor's Degree Required (scientific field preferred). Master's Degree in Quality, Regulatory Affairs , Pharmacy, Chemistry or Biology preferred. + 10+ years' ... ** Director , Quality** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to… more
- Stryker (Fremont, CA)
- …do:** **Technical Responsibilities:** + Works with Divisional Leadership, KOLs, Marketing, Clinical Affairs and Regulatory Affairs and regional organizations ... vetting with all internal stakeholders. + Works with Divisional Leadership, Marketing, Clinical Affairs and Regulatory Affairs and regional organizations to… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …current GMP, quality principles, and regulatory expectations to support relevant global regulatory submissions. + Authors, reviews and edits CMC sections and ... Collaborates with other external functions on CMC matters (eg, Quality, Commercial, Regulatory Affairs , etc.). Ensures the CMC function is adequately represented… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs . + Advanced knowledge of ... you and empower you to shine? Join us as Director , Quantitative Clinical Pharmacology (QCP) Lead in our Cambridge,... interactions. + Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …functions including but not limited to Translational Research & Biomarkers, Clinical Management, Global Regulatory Affairs , Global Clinical Development ... **Job Summary** The Senior Director will serve as the Translational Medicine CNS...(late phase), Data & Analytics, Early Commercial, Medical Affairs , Nonclinical Toxicology, Clinical Pharmacology, CMC, and Global… more
- ThermoFisher Scientific (Greenville, NC)
- …to producing compliant deliverables + Advanced, broad understanding of global /regional/national country requirements/ regulatory affairs procedures for ... trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; in-depth understanding of a regulatory … more
- BWX Technologies, Inc. (Oak Ridge, TN)
- …including environmental reviews, safety analysis, emergency preparedness, and NRC engagement. ** Regulatory Affairs & Licensing** + Direct all licensing ... engineering innovator that provides safe and effective nuclear solutions for global security, clean energy, environmental restoration, nuclear medicine and space… more
- J&J Family of Companies (Raritan, NJ)
- …Market Surveillance, Clinical Affairs , Design Quality Engineers, R&D, and Regulatory Affairs relating to literature search and systematic review processes. ... Experience within the medical device industry and with clinical evaluation report regulatory requirements **required** ; thorough understanding of global medical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …key stakeholders to establish strong working relationships with quality groups, colleagues in Regulatory Affairs , Global Trade Ops, Global Commercial ... across the US, Canada & LATAM regions. The Senior Director , Quality Assurance - Distribution will sit on the...hands-on experience supporting multiple QA operating models across a global commercial network and delivering successful governance & QA… more
- Sanofi Group (Cambridge, MA)
- …Research Director , Safety Officer and Pharmacovigilance, Translational Medicine, Regulatory Affairs , Biostatistics, Clinical Study Units, Medical Affairs ... **Job Title:** Development Scientific Director (DSD) **Location:** Cambridge, MA, **About the Job**...to the protocol development, study feasibility and risk assessment, regulatory submissions, protocol training, scientific review of data, and… more