- 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)
- We are seeking a Senior Director , Federal Government Affairs to lead our US federal government engagement in Washington, DC. This position reports to the ... the strategic leader, and a member of the Government Affairs Leadership Team, the Senior Director...Work with other relevant internal stakeholders (eg, Brand Teams, Regulatory Affairs , Market Access, Legal, Clinical) to… 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 ... engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs to develop and launch first in class and best… more
- Medtronic (Boston, MA)
- … Regulatory department and other business functions. This position reports to the Regulatory Affairs Director . Location: Strong preference to have a ... in a more connected, compassionate world. **A Day in the Life** The Senior Principal Regulatory Affairs Specialist will play a key role in creating … more
- Takeda Pharmaceuticals (Boston, MA)
- …probabilities of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices and… more
- Cardinal Health (Boston, MA)
- **_What Regulatory Affairs contributes to Cardinal Health_** Regulatory provides regulatory affairs and product development consulting services to ... submissions as well as clinical research and manufacturing process consulting. Regulatory Affairs plans, coordinates and implements regulatory strategies… more
- Takeda Pharmaceuticals (Boston, MA)
- … strategies in collaboration with their regional counterparts. **_Accountabilities:_** + The Senior Director will be responsible for complex or highly complex ... or oversees direct reports or other staff responsible. The Senior Director will lead all submission types....regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Takeda Pharmaceuticals (Boston, MA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... to the best of my knowledge. **Job Description** **Associate Director , US Advertising & Promotion Regulatory Review**... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Takeda Pharmaceuticals (Boston, MA)
- …primary liaison to the US FDA and provides support for regional and local regulatory affairs teams for interactions with international regulatory Agencies ... activities across the portfolio of PDT products. The Global Regulatory Lead, Director , in PDT R&D: +...related to assigned programs and supports regional and local regulatory affairs teams with health authority interactions.… more
- Sanofi Group (Cambridge, MA)
- **Job title** **_:_** Global Medical Senior Director Dermatology and Rheumatology, Pipeline Indications **Location:** Cambridge, MA **About the Job** Sanofi's ... in class therapeutic solutions that address highest unmet needs. The Global Medical Senior Director Dermatology & Rheumatology, Pipeline Indications will play a… more