- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + ... bring life-changing therapies to patients worldwide. Join Takeda as an Senior Manager, Global Regulatory Affairs, CMC Small Molecules where you will oversee… more
- Takeda Pharmaceuticals (Lexington, MA)
- …their teams in the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all ... Contribute to overall functional direction globally and represent function within CMC /Pharmaceutical Science and across the global Takeda organization. + Implement… more
- Sumitomo Pharma (Boston, MA)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the ... (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects.… more
- Bristol Myers Squibb (Devens, MA)
- …alongside some of the brightest minds in Biopharma. **Position Summary** The Senior Director , Head of Potency and Impurity Assay Development (PIAD) ... the next generation of scientific and organizational leaders. **Key Responsibilities** The Senior Director , Head of Potency and Impurity Assay Development… more
- Orchard Therapeutics (Boston, MA)
- …closely collaborate with the assigned US Regulatory lead, their peers in Europe, the Regulatory CMC team and the VP of Regulatory Science, to ensure a ... Location: Boston, MA Main responsibilities The Executive Director (ED) Regulatory Science will actively...technical development of gene or cell-based therapies and associated regulatory CMC activities is not requested. .… 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
- 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 ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Senior Program Leader, Global Device Development ( Sr . Director ) **Location:** Morristown, NJ Cambridge, MA **About the Job** We deliver 4.3 ... capacities. Within Sanofi`s Global Device and Packaging Unit, as senior program leader you will play a pivotal role...and GDPQ, QA/RA, M&S Site and global functions, MSAT, CMC teams and external partners, assigned to the program.… 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