- Takeda Pharmaceuticals (Boston, MA)
- …what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management ... requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market… more
- Lilly (Boston, MA)
- …determined to make life better for people around the world. **Job Summary** The Director /Senior Director , CMC , Drug Product Development will lead formulation ... capabilities in drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to drug product development and… more
- Sumitomo Pharma (Boston, MA)
- …of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions ... a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director is… more
- Sanofi Group (Framingham, MA)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** Are ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The… more
- Takeda Pharmaceuticals (Boston, MA)
- …we do begins with our commitment to putting patients first. As the Director , Technology Business Partner for Pharmaceutical Sciences R&D Data Digital and Technology ... as a strategic advisor and technology domain expert for Pharmaceutical Sciences/ CMC scientific and clinical manufacturing informatics and digital solutions +… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …strategy), site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC . + Provide technical support to marketing ... best of my knowledge. **Job Description** **About the role** As Associate Director , API Process Engineering, you will be Takeda's global expert for small-molecule… more
- Takeda Pharmaceuticals (Boston, MA)
- …Pharmaceutical Sciences counterparts. + Other key functional groups such as Global Quality, Regulatory CMC etc. **Leadership** + Provide vision and strategy for ... Description** **Title: Process Engineer Small Molecules API Process Science (Associate Director )** **Location: Cambridge, MA (Hybrid)** **About the role:** As a… more
- Takeda Pharmaceuticals (Boston, MA)
- …roles, with deep expertise across Pharmaceutical Sciences + Strong understanding of CMC processes, GxP, regulatory compliance and global quality standards + ... & Technology (DDT) portfolio driving innovation and operational excellence across the CMC lifecycle. This leadership role is accountable for shaping and delivering… more
- Amgen (Cambridge, MA)
- …Join us and transform the lives of patients while transforming your career. ** Director , Commercial Drug Products & Life Cycle Management** **What you will do** Let's ... leader in delivering superior, robust drug product manufacturing processes, high-quality CMC sections, and ensuring supply of commercial products. Drug Product Team… more
- Otsuka America Pharmaceutical Inc. (Waltham, MA)
- **Job Summary** The Senior Director will serve as the Translational Medicine CNS Therapeutic Area Head, reporting to the VP, Translational Medicine and Early ... Clinical Development within OPDC's Early Development Organization (EDO). The Senior Director Translational Medicine will oversee a small team of CNS Translational… more