- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs ( RA ) CMC project representative to ... higher-level manager. + ** Regulatory Knowledge:** Demonstrates expert knowledge of US/EU regulatory guidances. Serves as RA CMC representative supporting… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** The Associate Director , Analytical Regulatory Science, collaborates with ... for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure... Team Leads to provide one CMC RA voice to PDM project teams regarding regulatory… more
- Ascendis Pharma (Palo Alto, CA)
- …We offer a dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for ... developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC ...complex and require extensive interaction with departments outside of regulatory affairs . + Excellent organizational skills and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- AbbVie (North Chicago, IL)
- …and global interfaces across Small Molecule and Biologics Analytical R&D functions (SMARD/BARD), CMC Regulatory Affairs ( RA ), Quality Assurance (QA), ... functional vision into actionable strategies. + Stays current on global regulatory expectations and trends (via guidelines, GMPs, trade organizations, and other… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Outsourcing & Vendor Management Pleasanton, CA, USA * Princeton, NJ, USA Req #385 Friday, August 16, 2024 Looking for a chance to make a ... dynamic and expanding mid-size company in the role of Associate Director , Outsourcing and Vendor Management. Your...clinical operations, data management, Pharmacovigilance Operations, Medical Writing and Regulatory Affairs is a plus. + CPM… more
- Merck (Rahway, NJ)
- **Job Description** Under minimal guidance of the Executive Director / Director / Associate Director , Pharmacovigilance (PV) Partner Strategy & Management ... and SMPs. + Maintains, in collaboration with the Executive Director / Director / Associate Director ...all levels of management within and outside of Global Regulatory Affairs and Clinical Safety (GRACS). +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …such as Pharmaceutical Development & Manufacturing (PDM), Quality, Supply Chain, Manufacturing, Regulatory Affairs CMC , Finance, and Technical Development ... more than 35 countries worldwide, with headquarters in Foster City, California. ** Associate Director - Material Science** **(Pivotal & Commercial Biologics)**… 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