- Teva Pharmaceuticals (Parsippany, NJ)
- …Development Lead, Clinical Scientist. and other functional areas such as GCO, biostats, regulatory , pharmacovigilance. The Director will be a key contributor to ... INDs, NDAs, BLAs, and other global regulatory filings and publications. The Director will...Operating Procedures + Partners cross-functionally with departments such as Regulatory Affairs, CMC , Biostatistics, GCO, in the… more
- Veterans Affairs, Veterans Health Administration (Philadelphia, PA)
- …precision mental health care. 2. Provides consultation to investigators on all regulatory oversite of the research portfolio and in particular clinical trials. ... and family psychotherapy. 5. Provides consultation to professional staff within CMC VAMC system and to community providers, concerning clinical assessment findings… more
- Capgemini (New York, NY)
- …(no sponsorship). **Preferred** + Former **FDA/CDER/CBER** reviewer experience. + VP/ Director Regulatory experience in **first-time submissions** (IND → ... **Your Role** As a Senior Consultant, you'll act as a **trusted regulatory advisor** for pharma and biotech clients, leading engagements on **submission readiness… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …development, distribution, importation, export, and vendor management in cooperation with Director of Commercial Supply Chain. This incumbent will drive supply chain ... and external stakeholders; as well as cooperating with and supporting the Director , Commercial Supply Chain. This incumbent will set up the coordination,… more
- J&J Family of Companies (Spring House, PA)
- …by generating hypotheses and investigative strategies. + Accountable for global regulatory nonclinical documents and health authority responses to support clinical ... as needed. + Collaborate proactively with Chemistry, Manufacturing and Controls ( CMC ) functions to assure drug substance quality. + Participate in external… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …+ Play a strategic role on preclinical vaccine development related issues relevant to CMC and regulatory interactions. + Identify and cultivate partners to build ... You'll Do + Partner closely with team leadership, including the Director , Accelerator and Distinguished Fellow, AI-Enabled Cures Frontier, to develop, communicate,… more
- Kelly Services (Tarzana, CA)
- …science or engineering discipline. * Understanding of cGMP process and knowledge of CMC regulatory framework for biologics. * Knowledge of aseptic techniques for ... Monica, CA as needed. The contractor will report to the Associate Director of Manufacturing, NGF70. The Specialist, Manufacturing role will ensure successful… more