- Gilead Sciences, Inc. (Foster City, CA)
- …be accountable for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally. ... Join Gilead and help create possible, together. **Job Description** The Associate Director, Analytical Regulatory Science, collaborates with product development,… more
- 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 the ... years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry experience… more
- Ascendis Pharma (Palo Alto, CA)
- …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)
- …The 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
- 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
- Taiho Oncology (Princeton, NJ)
- …such as clinical operations, data management, Pharmacovigilance Operations, Medical Writing and Regulatory Affairs is a plus. + CPM or CPIM certification ... Associate Director, Outsourcing & Vendor Management Pleasanton, CA,...CROs, Central Lab, IRT, IRBs, Wearables, Investigators sites, Medical Affairs , HEOR, CMC and other related ancillary… 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), CMC ... functional vision into actionable strategies. + Stays current on global regulatory expectations and trends (via guidelines, GMPs, trade organizations, and other… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. Purpose The Global Regulatory Affairs (GRA) Labeling Implementation drives the timely and high-quality ... maintenance of product labeling in the assigned country/region. The Global Regulatory Affairs (GRA) Labeling Implementation develops collegial, mutually… more
- Gilead Sciences, Inc. (Foster City, CA)
- …such as Pharmaceutical Development & Manufacturing (PDM), Quality, Supply Chain, Manufacturing, Regulatory Affairs CMC , Finance, and Technical Development ... than 35 countries worldwide, with headquarters in Foster City, California. ** Associate Director - Material Science** **(Pivotal & Commercial Biologics)** **Role… more
- Merck (Rahway, NJ)
- …be able to work with all levels of management within and outside of Global Regulatory Affairs and Clinical Safety (GRACS). + Interact closely with the system ... differences **Preferred Experience and skills:** Five years' experience in Pharmacovigilance/ Regulatory / CMC /Quality/Clinical **NOTICE FOR INTERNAL APPLICANTS** In accordance… more
- IQVIA (Durham, NC)
- …rendered will adhere to applicable Johnson & Johnson SOPs, Wis, policies, local regulatory requirements, etc. + Co-author of the IPPI and review/provide input on all ... supply related questions in close collaboration with the Ancillary Support Associate (ASA)/ Site Manager (SM). + Develop IP administration training materials.… more