- Aequor (NJ)
- …Global Study Management and Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory , CMC , QA, Packaging Vendors, CRO's, ... studies during phases 1-4. The individual must partner closely with clinical, regulatory , quality and production associates to ensure timely delivery of supplies to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …training, etc. with minimal guidance. + Leads the planning, logistics, and scheduling for CMC Regulatory Affairs Leadership Team meetings and any other ... and manage managers calendar's (including Pharmaceutical Development & Manufacturing Leadership Team, CMC Regulatory Affairs Leadership Team OOO calendars) +… more
- Merck (Kenilworth, NJ)
- …and Development GMP laboratories, Biologics Process Research and Development, Global Quality and Regulatory Affairs - CMC , and our partners in in the ... deadlines + Authoring and reviewing internal technical reports, sections of regulatory filings (eg, IND, BLA) and external scientific publications + Experience… more
- Organon & Co. (Plymouth Meeting, PA)
- …Position** The Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule products in ... business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to...the product lifecycle. + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC… more
- University of Maryland, Baltimore (Baltimore, MD)
- …in the MS in Regulatory Science program, with a focus on introductory and regulatory affairs aspects of the program, as well as another aspect of the program ... AREAS OF EXPERTISE AND EXPERIENCE_* Regulatory science, including introductory and regulatory affairs aspects, as well deep knowledge in another aspect (eg… more
