- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... GMP relevant activities involving but not limited to supplier qualification program, CMC audit, clinical/IMP vendor audits and overall GMP vendor audit program.… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Director , Biopharmaceutics will provide expert biopharmaceutical guidance on the pharmacokinetic performance ... for the general medicines portfolio of products marketed worldwide. The Associate Director , Biopharmaceutics will also be responsible for contributing… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... future of science, we're in. Are you?About the Role:We're looking for an Associate , Regulatory Operations on the Regulatory team to help us expand what's possible… more
- Insmed Incorporated (NJ)
- …expand what's possible for patients with serious diseases. Reporting to the Associate Director , Regulatory Affairs, Tactical Implementation, you'll have a ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...assigned programs and market. Under the guidance of the Associate Director , you will ensure high-quality, timely,… more
- Lilly (Philadelphia, PA)
- …are determined to make life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory will leverage CMC ... regulatory strategies for investigational and commercial radiopharmaceutical products. + Lead global CMC regulatory submissions including authoring, review, and… more
- BeOne Medicines (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. **Essential… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Associate Director - CMC BioDPDM **Location** : Framingham, MA As Associate Director within CMC BioDPDM, you'll have the opportunity ... could turn the impossible into possible for millions. The Associate Director role is a key leadership...Director role is a key leadership role in CMC Biologics Drug Product Development and Manufacturing. You will… more
- Sumitomo Pharma (Lincoln, NE)
- …of ** Associate Director , Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the ... registration strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead ( Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... portfolio of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The GRA Device organization serves as a critical strategic… more
- Takeda Pharmaceuticals (Boston, MA)
- …GMSci DP/PKG** **Location: Cambridge, MA** **About the role:** As a Process Scientist ( Associate Director ) - Global Manufacturing Science GMSci Drug Product ... regulatory interactions, including the preparation of Chemistry, Manufacturing, and Controls ( CMC ) content for dossiers. Additionally, you will ensure that process… more
