- Sanofi Group (Framingham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown, NJ **About the Job** Are you ready to shape the future of ... through strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role… more
- Sanofi Group (Waltham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA/ Waltham, MA/ Morristown, NJ **About the Job** Are you ready to shape the ... we chase the miracles of science to improve people's lives. The Global Regulatory Affairs (GRA) CMC & Device Organization within Sanofi R&D serves as a… more
- Parexel (Boston, MA)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional...regulatory efficiency and readiness * Participate in monthly CMC Global Regulatory Team meetings… more
- Sanofi Group (Cambridge, MA)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... and Development. Sanofi's global regulatory affairs (GRA) function is comprised of more than 1800...perspective as a member of project specific cross functional global regulatory team (GRT) and is accountable… more
- Parexel (Boston, MA)
- …development and approved programs, helping to shape the future of life-saving therapies. As a ** CMC Regulatory Affairs Senior Associate** , you will play a ... lifecycle management. **Key Responsibilities** + Develop and implement comprehensive global CMC regulatory strategies for...(advanced degree preferred). + 4+ years of experience in CMC Regulatory Affairs within the… more
- Sanofi Group (Framingham, MA)
- …non-viral LNPs), with teams in France, Germany and the USA. Reporting to the head of Global CMC Development, this highly visible role has the potential to make a ... **Job Title:** Global Head, BioAnalytics, CMC Development **Location**...and with other Sanofi functions (eg, Research, Quality Assurance, Regulatory Affairs , Manufacturing & Supply, Business Development).… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement CMC strategies to enable data driven ... shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior...realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation,… more
- Takeda Pharmaceuticals (Boston, MA)
- …with functional areas from quality, process experts, product experts, device experts, and regulatory affairs . + Works with supervisor for alignment on project ... risk management, line extensions & discontinuation, launch execution & global expansion/contraction, COGs management, regulatory activities, product /… more
- Sumitomo Pharma (Boston, MA)
- …Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will ... of the product + Supports the global regulatory lead (GRL) and the CMC ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Sumitomo Pharma (Boston, MA)
- …position of **Director Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... function as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
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