- Aequor (Thousand Oaks, CA)
- …this role? 3. Based on the job description, what do you understand this role to be?The Associate Regulatory Affairs ( CMC ) role is an entry level ... requested. What we are looking for: Desire to learn Regulatory Affairs CMC and global...Compliance, Quality, Biopharmaceutical, Pharmaceutical or related scientific experience OR Associate degree and 6 years of either Regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations through internal ... disorders.Summary The Associate Director, RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and Controls) activities from early… more
- Bristol Myers Squibb (Princeton, NJ)
- …to build/maintain database to address external questions regarding drug products. The CMC Regulatory Associate Director, Biologics is responsible for ... a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key...HA meetings); and/or post-approval submissions. In this role, the GRS- CMC Associate Director, Biologics will serve as… more
- Teva Pharmaceuticals (West Chester, PA)
- …4 direct reports (Dir, Sr Manager, Manager & Associate III). The Sr Director, Regulatory Affairs CMC is responsible for identifying and evaluating CMC ... Senior Director Regulatory Affairs CMC (Biologic Products) Date: Jul 12, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva… more
- 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
- 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
- Amgen (Washington, DC)
- …regulatory , CMC , manufacturing, testing or process/product development experience OR Associate 's degree and 10 years of regulatory , CMC , ... strategies, submissions, and plans. This position will support: + Global regulatory CMC activities relevant to the successful execution and implementation of… 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
- Sanofi Group (Cambridge, MA)
- …products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... **Job title: Device Regulatory Lead ( Associate Director)** + Location:...PA or Cambridge, MA **About the job** The Global Regulatory Affairs Device team is a globally… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations through internal ... Associate Director, RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and Controls) activities...scientific/ regulatory fields required - Experience in international Regulatory Affairs - CMC preferred Daiichi… more
- Takeda Pharmaceuticals (Boston, MA)
- …Analytical Development, Drug Product Development, and adjacent functions (such as QC, QA, CMC regulatory affairs , clinical supply chain) with full ... Chemistry (PC) team in SMPD. Join Takeda as an Associate Scientific Fellow, Process Research (PR) where you will...support of the development and implementation of an overall CMC strategy. + Lead all or part of 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
- Gilead Sciences, Inc. (Foster City, CA)
- …and conduct investigations in a collaborative multidisciplinary environment. + Work with Regulatory Affairs & Quality Assurance to ensure that all applicable ... and help create possible, together. **Job Description** **Senior Research Associate I, Analytical Development and Operations** **(** **Method Validation Transfer… more
