- Takeda Pharmaceuticals (Boston, MA)
- …of what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant ... based on risk and scientific rationale. + Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** As a CMC Lead, Small Molecules (Associate Director ), you will be responsible for leading ... to the world. **How you will contribute:** + Provide strong direction to CMC Leads to drive effective life cycle management for Takeda's commercial small molecule… more
- Bristol Myers Squibb (Devens, MA)
- …to ensure product quality, compliance and supply. + Author, review and approve regulatory CMC submission sections. + Drive continuous improvement initiatives to ... influencing external partnerships (CDMOs/CMOs) to achieve strategic outcomes. + Knowledge of CMC regulatory , drug substance & drug product manufacturing, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …Sciences counterparts. + o Other key functional groups such as Global Quality, Regulatory CMC etc. **Leadership** + Provide vision and strategy for manufacturing ... true to the best of my knowledge. **Job Description** **Title: Associate Director -Process Engineer SM API Process Sci** **Location: Cambridge, MA (Hybrid)** **About… more
- Sanofi Group (Framingham, MA)
- …(60% on- site ) and comprehensive well-being programs. + Influence global regulatory strategies, interact with key health authorities, and stay at the forefront ... **Job Title:** GRA Device Lead (Associate Director ) **Location** : Morristown, NJ/ Cambridge, MA/ Framingham,...critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse… more
- Sanofi Group (Cambridge, MA)
- …(60% on- site ) and comprehensive well-being programs. + Influence global regulatory strategies, interact with key health authorities, and stay at the forefront ... **Job Title:** GRA Device Lead (Associate Director ) **Location:** Cambridge, MA/ Morristown, NJ **About the...critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse… more
- Bristol Myers Squibb (Devens, MA)
- …for: + Technology transfer and process validation across the product lifecycle + CMC lifecycle management and regulatory strategy + Oversight and governance of ... harmonization, and standardization to ensure global manufacturing scale-up, reliability, and regulatory compliance We are seeking a strong strategic technical leader… more
- CSL Behring (Waltham, MA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . *Applies the CSL Leadership Capabilities - Build Bridges, ... and is onsite three days a week. You will report to the Executive Director Head Regulatory . **Position Description** **Summary** * Regulatory leaders who… more