- Lilly (IN)
- …collaborate with team members across functions including but not limited to clinical operations, CMC , regulatory affairs , and QA. + Working knowledge of ... Loxo@Lilly:** Loxo@Lilly (L@L) conducts discovery research, clinical development, and regulatory affairs for oncology, with the goal...early 2019. The unit has team members in Boulder, CO , Indianapolis, IN, New York City, South San Francisco,… more
- Organon & Co. (Jersey City, NJ)
- …regulatory strategies. + Prepare and review information required for development of regulatory CMC dossiers for commercial products. + Provide input to global ... milestones for assigned products across the product lifecycle. Identify and communicate potential regulatory issues to Organon Regulatory CMC management, as… 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
- Bill and Melinda Gates Foundation (Seattle, WA)
- …of product development for our priority diseases, in the domains of regulatory affairs , quantitative sciences, chemistry manufacturing & controls, and clinical ... deliverability targets. + Play a strategic role in addressing CMC -related issues pertaining to regulatory interactions and...led by CEO Mark Suzman, under the direction of co -chairs Bill Gates and Melinda French Gates and the… 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