- Novo Nordisk Inc. (Plainsboro, NJ)
- …personnel in other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...appropriate individuals. Ability to work with less supervision than Associate . Take initiative to assist with overflow in other… 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
- 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: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva… more
- Lilly (Indianapolis, IN)
- …around the world. Organization Overview: The Global CMC Regulatory Associate , Global Regulatory Affairs (GRA) Regulatory Delivery Excellence ... + Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director, Regulatory Affairs - Remote OR West Chester, PA Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: ... difference with. **How you'll spend your day** As the Associate Director, Regulatory Affairs you...of the regional, clinical and Chemistry Manufacturing and Controls ( CMC ) regulatory strategies with the overall global… more
- Novo Nordisk (Plainsboro, NJ)
- …personnel in other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...appropriate individuals. Ability to work with less supervision than Associate . Take initiative to assist with overflow in other… more
- Organon & Co. (Plymouth Meeting, PA)
- …The Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule products in accordance ... 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
- 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 (Swiftwater, PA)
- …products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... **Our Team:** The Global Regulatory Affairs Device team is a globally diverse team supporting the medical device, combination product, digital health and… more
- Sanofi Group (Bridgewater, NJ)
- …pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global) especially in ... team** The team is involved in developing and executing regulatory strategies for Tzield in life cycle development stages...strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with… more
- AbbVie (Madison, NJ)
- …multiple driver indications within a Therapeutic Area and support the Manager, Global Regulatory Lead (GRL), Associate Director, or Director, in the development ... . Advise internal customers who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, Legal, and… 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
- Takeda Pharmaceuticals (Lexington, MA)
- …and program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC , Marketing). + Minimum… 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
- Actalent (Paramus, NJ)
- …requests (ARIBA), and monitoring of project financial tracking. + Assist and support Regulatory Affairs (RA) to provide any documents for their submissions (US ... Job Description: + Assist and support the Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Clinical Supplies. +… more
