- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs , Neuroscience is responsible for ... appropriate regulatory strategy. + Participates in cross-functionalinitiativeswithin Global Regulatory Affairs and Takeda R&D. **How you will contribute:**… more
- Takeda Pharmaceuticals (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Rhythm Pharmaceuticals (Boston, MA)
- …learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be responsible for ... cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs . Responsibilities...core values are: + We are committed to advancing scientific understanding to improve patients' lives + We are… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …stem cell transplant. In this position you will build and lead a cell medicine regulatory affairs team and provide regulatory leadership and oversight to the ... development of innovative regulatory affairs and CMC regulatory ...scientific content. + Build, lead and mentor the regulatory team and provide project teams with the strategic… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to ... and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance...8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record of… more
- Takeda Pharmaceuticals (Boston, MA)
- …of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally ... NDA, 510K, CE Mark submissions and their amendments/supplements). + Understanding of scientific principles and regulatory Device requirements relevant to global… more
- Bristol Myers Squibb (Cambridge, MA)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Sumitomo Pharma (Boston, MA)
- …, Medical Strategy (Prostate Cancer)** will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... and with alliance partners. + Oversee the strategy and development of Medical Affairs plans and scientific platforms. + Ensure cross-functional medical alignment… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …value and real-world evidence, US and global commercial teams, market access, and regulatory affairs , to ensure integrated global strategies and cohesive medical ... disorders, we are seeking a skilled and experienced Medical Director of CNS Early Assets, Global Medical Affairs...or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical… more
- Takeda Pharmaceuticals (Lexington, MA)
- …People leadership experience (5+ years) required. + Highly proficient understanding of scientific principles and profound grasp of global regulatory CMC ... as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA… more