- Sumitomo Pharma (Boston, MA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She...the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Global Regulatory Affairs Device Lead ( Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... 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)
- …Regulatory data models, RIM systems (Veeva Vault preferred)** , and Regulatory processes (Labeling, CMC , Registrations). + Excellent analytical and ... the best of my knowledge. **Job Description** **Summary:** The Regulatory Data Governance Lead will ensure Regulatory ...The Regulatory Data Governance Lead will ensure Regulatory information and data standards are aligned with Takeda's… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- ** Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** **Title: Associate Director -Process Engineer SM API Process Sci** **Location: Cambridge, MA ... (Hybrid)** **About the role:** As an Associate Director -Process Engineer SM API Process Sci,...o Other key functional groups such as Global Quality, Regulatory CMC etc. **Leadership** + Provide vision… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** GRA Device Lead ( Associate Director ) **Location** : Morristown, NJ/ Cambridge, MA/ Framingham, MA **About the Job** Are you ready to shape the ... 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
- Sanofi Group (Waltham, MA)
- **Job Title:** Associate Director , Genomic Medicine Purification Process Development **Location:** Waltham, MA Work Model: M-F onsite **About the Job** Are you ... our teams accelerate progress. The Genomic Medicine Unit (GMU) CMC group at Sanofi is dedicated to the establishment...Group located in Waltham, MA in the role of Associate Director . The GMU PPD group operates… more
- Amgen (Cambridge, MA)
- …and transform the lives of patients while transforming your career. **Process Development Associate Director ** **What you will do** Let's do this! Let's change ... that deliver robust drug substance commercialization data packages (including authoring of CMC sections of regulatory documents, interaction with regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …DP/PKG** **Location: Cambridge, MA** **About the role:** As a Process Scientist ( Associate Director ) - Global Manufacturing Science GMSci Drug Product (DP), ... and the life cycle management of existing products. You will lead regulatory interactions, including the preparation of Chemistry, Manufacturing, and Controls (… more