- Medtronic (Mansfield, MA)
- …in a more connected, compassionate world. **A Day in the Life** We are seeking a Senior Regulatory Affairs Specialist to join our team within Medtronic Acute ... in regulatory affairs **Nice to Have** + 4+ years of medical device regulatory affairs experience + Local to CO and willing to work hybrid for… more
- Medtronic (Boston, MA)
- …to innovation in a more connected, compassionate world. **A Day in the Life** The Senior Principal Regulatory Affairs Specialist will play a key role in ... develop the global regulatory strategy and support regulatory activities throughout the product lifecycle. The senior... regulatory affairs group to support regulatory submissions worldwide for Class II medical … 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, ... business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, … 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)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project ... ensure Otsuka's products are developed/maintained in compliance with global regulatory requirements and guidances. Primary regions/markets of responsibility include… more
- Fresenius Medical Center (Waltham, MA)
- …MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership in medical /clinical development, commercial, and other functional areas ... (Advanced degree such as a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred. + **Experience:** + 12+ years… 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...for in a multitude of public policy, legislative, and regulatory regimes and initiatives. Key Responsibilities Serve as the… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is ... you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you...Advisor and function as the "R" in the core Medical , Legal, and Regulatory review functions within… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Medical Affairs Senior Director Kevzara **Grade:** L4-2 **Location** : Cambridge, MA **About the Job** In order to pursue Sanofi's ... miracles of science to improve people's lives", Specialty Care Medical Affairs have a vision to be...engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs … more
- 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