- Fresenius Medical Center (Waltham, MA)
- …RAC) is preferred. + **Experience:** + 12+ years of experience in regulatory affairs , focusing on regulatory strategy , submissions, and global market access in ... development, approval, and market access for FME's product portfolio. The Global Strategy Leader will work closely with internal and external stakeholders to align… more
- Takeda Pharmaceuticals (Boston, MA)
- …representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead discussions of regulatory strategy with senior ... strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory… more
- Rhythm Pharmaceuticals (Boston, MA)
- …and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be responsible for ensuring ... commercialization and life cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs . Responsibilities and Duties + Act as the… more
- Takeda Pharmaceuticals (Boston, MA)
- … strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory ... strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …hematologic, and other complex diseases. The Head of Global Regulatory Affairs Operations, Compliance & Process Excellence is accountable for overseeing Global ... Regulatory Affairs Operations across the entire PDT BU portfolio of...will resolve or simplify complexity between commercial, operations, and strategy . + Resilient and comfortable working through large scale… 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 shape ... **About You** **Experience:** + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record of **relevant… more
- United Therapeutics (Boston, MA)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic or pharma ... with a Master's Degree in life sciences, quality, regulatory affairs or a related area of study or 7+...submissions + Proven ability to lead and influence data-driven strategy planning and implementation + Strong leadership and communication… more
- Takeda Pharmaceuticals (Boston, MA)
- … director will provide scientific & team leadership, guidance across global medical affairs activities including evidence data generation, data analysis and ... will work in a multifunctional, matrix organization with other medical affairs functions (global medical ...will be accountable for development and execution of asset medical strategy and tactics, as well as… more
- Danaher Corporation (Boston, MA)
- …which makes everything possible. The Senior Principal, Regulatory Affairs is responsible for regulatory strategy development ... projects, engaging with global regulatory agencies, and steering regulatory strategy for new product development and strategic initiatives. By...in the Biopharma sector. This position reports to the Director , Regulatory Affairs and is part of… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …inform brand strategy and decision-making. + Collaborate cross-functionally with Medical Affairs , Compliance, Legal, and Commercial teams to ensure advisory ... and policies. + Collaborate with internal cross-functional stakeholders (Marketing, PRT, Medical Affairs , Legal, Regulatory, Ethics & Compliance) to ensure… more