- 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
- 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
- Amicus Therapeutics (Marlow, OK)
- Associate Director CMC RA Location Marlow, UK...matter experts in Tech Ops, Science, Quality and Global Regulatory Affairs to ensure timely delivery of ... deliverables and ensuring seamless communication. The candidate will ensure all CMC regulatory submissions (such as pre-submission consultation package, review… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director, Regulatory Affairs - West Chester, PA Date: Mar 26, 2024 Location: West Chester, United States, 1938 Company: Teva Pharmaceuticals Job ... 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
- J&J Family of Companies (Columbus, OH)
- Associate Director, Regulatory Affairs - 2406166277W **Description** Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of ... Companies, is recruiting for an Associate Director, Regulatory Affairs . This...alignment with NA regional teams, Chemistry, Manufacturing, and Controls ( CMC ), commercial strategies, and the Target Product Profile. +… 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
- 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
- Sanofi Group (Bridgewater, NJ)
- …pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global) especially in ... **Main responsibilities:** + Leads the US regulatory activities. + As a key member of...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
- Sumitomo Pharma (Columbus, OH)
- …changes to contract manufacturing organizations, testing laboratories, clinical sites and regulatory affairs as needed. + Responsible for compliance with ... global contract testing laboratories in partnership with the Company's CMC Team. The Associate Director also participates...for marketed pharmaceutical products or clinical trial materials. Review regulatory IND, IMPD, CTD and BLA/NDA CMC … 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
- AbbVie (Irvine, CA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Regulatory Affairs - Device/Combination products supports regulatory ... process. Experience with eCTD tools and EDMS applications. + Background in regulatory affairs , manufacturing, marketing, or quality assurance sufficient to… more
- Randstad US (North Billerica, MA)
- …and make it happen skills: HPLC, SOP, GLP (Good Laboratory Practice), Regulatory Affairs Operations Equal Opportunity Employer: Race, Color, Religion, Sex, ... associate research scientist. + north billerica , massachusetts...Operations, including: InfoLinx archiving systems, Radionuclide databases, SOP systems, CMC submission document preparation within R&PD, training modules and… more
