- Takeda Pharmaceuticals (Boston, MA)
- …and tracking of required actions until completion + Monitor progress toward Global Regulatory Affairs KPIs, intervening as necessary to ensure that Regulatory ... experience in at least one of the following: clinical development, pharmacovigilance, regulatory affairs or clinical supplies + Experience in R&D operations… 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
- 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 ... + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record of **relevant advertising & promotion … 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 ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices and… more
- BeOne Medicines (Cambridge, MA)
- BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Director, Regulatory Affairs in Cambridge, MA, USA: **Job Duties:** + Provides high level regulatory strategic ... direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Beth Israel Lahey Health (Boston, MA)
- …you're making a difference in people's lives.** The Manager of Business and Regulatory Affairs oversees financial performance, regulatory compliance, and ... workflows and managed care contracting. (essential) 4. Maintains knowledge of regulatory requirements specific to transplant programs including the OPTN/UNOS and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA ... and other unique modalities + Represents, contributes and influences Regulatory , Pharmaceutical Development, and Commercial project teams throughout clinical… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …brand objectives. Work with other relevant internal stakeholders (eg, Brand Teams, Regulatory Affairs , Market Access, Legal, Clinical) to help anticipate, ... We are seeking a Senior Director, Federal Government Affairs to lead our US federal government engagement...for in a multitude of public policy, legislative, and regulatory regimes and initiatives. Key Responsibilities Serve as the… 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 ... (T0 - T1) or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical Development is preferred. + Minimum of 7+… more