- Novo Nordisk (Lexington, MA)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... functional areas. Relationships You will report to the Senior Director , Regulatory Affairs (based in Lexington). Essential...and deliver on associated regulatory activities + Lead the Global Regulatory Matrixed… more
- ThermoFisher Scientific (Waltham, MA)
- … regulatory professionals within this business area. **What Will You Do?** + Regulatory lead for the LED business. Partners with business leads to advise ... significant contributions to the world. **Discover Impactful Work:** The Director of Regulatory Affairs (RA) is responsible...global Q&RA system efficiencies to meet customer and global regulatory standards + Reviews and approves… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- In this key leadership role, you will build and oversee Global Regulatory Science and Regulatory CMC strategic framework and will support driving ... cell transplant. In this position you will build and lead a cell medicine regulatory affairs team...Responsible for the strategic company guidance on FDA and global regulatory requirements (affairs and CMC) for… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …**OBJECTIVES:** + Collaboration with functional Medical Affairs partners (including Global Medical Leads, Scientific Communications, Evidence Generation and LOC ... the ITP and IgAN Training Council to oversee development of the Immunology (ITP/IgAN) Global Medical training plan + Oversight of the execution and delivery of the… more
- Sanofi Group (Cambridge, MA)
- …decision-making. The Medical Director will collaborate with internal experts from Global and Local Medical, Clinical Development, and Regulatory teams to ... **Job title** : Global Medical Director , Evidence Generation -...Immunology disease areas of interest. Reporting directly to the Global Medical Evidence Generation Lead of the… more
- Bristol Myers Squibb (Cambridge, MA)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director , Global Regulatory Strategy, Neuroscience** **Position ... Summary:** The selected candidate will have leadership responsibility for global regulatory strategy within a development team...strategy within a development team (DT). Serve as team lead or co- lead of marketing application submission… more
- Sanofi Group (Cambridge, MA)
- …Market + Track record of successful cross-functional collaboration + Familiarity with global regulatory environments and requirements + Experience in lifecycle ... **Job title** **_:_** Global Medical Senior Director Dermatology and...indications for Sanofi across dermatology and rheumatology. This senior director level position (L4-2) will lead strategic… 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 purpose ... exchange and engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs to develop and launch first… more
- Sanofi Group (Cambridge, MA)
- …diagnostic products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within ... **Job title** : GRA Device Lead (Associate Director ) **Location:** Cambridge. MA...key regulatory activities and report to the Global Regulatory Device Head for Digital Health… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …that will inspire you and empower you to shine? Join us as an Associate Director , Global Program Management in our Cambridge, MA office. At Takeda, we are ... people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …development and commercialization of new and innovative therapies. Assigned to one or more global product(s), or as the lead for a disease area within GEO, ... evidence generation sub team for products under development, and working with global , regional and local cross-functional colleagues lead the development of… more
- Sanofi Group (Cambridge, MA)
- **Job title:** Senior Global Medical Director Ophthalmology **Location:** Cambridge, MA **About the Job** In order to pursue Sanofi's purpose of "Chasing the ... exchange and engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs to develop and launch first… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Lead , Sr. Director - In-Vitro Diagnostics Development **Location:** Cambridge, MA - Bridgewater, NJ **About the job** The strategic vision of ... Sanofi's Global Device & Packaging Unit is to ...role will closely work with GDPU leadership, program leaders, global quality, regulatory as well as R&D… more
- Sanofi Group (Cambridge, MA)
- …Your skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs (GRA)-Advertising and Promotion (A-P) ... several activities for Global A-P including but not limited to: + Lead organizational engagement activities to support cultural change aligned with Sanofi Play 2… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …functional leadership, as part of the overall Asset Strategy in the Discovery, Global Product Teams, and Medical sub-teams through all stages of discovery, clinical ... define candidate biomarkers for mechanisms of action and drug response. + Lead Translational Biomarker strategy development and execution to support the pre-clinical… more
- Bristol Myers Squibb (Cambridge, MA)
- …lives. Read more: careers.bms.com/working-with-us . The Clinical Scientist Program Lead reports through the Clinical Science function which provides scientific ... Objective** + Partners with Clinical Scientist Head to plan, lead , and advance programs and talent + Serves as...of innovative protocols and data packages for CSRs and Regulatory Filings + Oversees all clinical studies within assigned… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …(eg TGRD and TPNA/TPEU/TPC). Lead TGRD internal teams and may lead global cross-functional teams, as appropriate. . Hires, manages, mentors, motivates, ... relevant to mechanism of action . Preferably with expertise in nephrology . Regional/ global Regulatory requirements . GCP/ICH . Emerging research in designated… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …divisions (eg TGRD and TPNA/TPEU/TPC). Lead TGRD internal teams and may lead global cross-functional teams, as appropriate. + Hires, manages, mentors, ... + Therapeutic area knowledge relevant to mechanism of action + Regional/ global Regulatory requirements + Emerging research in designated therapeutic… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Senior Director , Global Lead Buyer - Advanced Sourcing **Location** : Bridgewater NJ, > Morristown NJ (March 2025), Cambridge MA, Framingham ... that meets the evolving needs of our stakeholders, business and regulatory environment. Additionally, Global Lead Buyer - Advanced Sourcing will focus on… more
- Novo Nordisk (Lexington, MA)
- …medical/ scientific documents, safety monitoring, and data analyses. The Senior International Medical Director will also take medical lead in the development and ... About the Department Our East Coast Global Development Hub brings together the best minds...make a difference? The Position The Senior International Medical Director serves as a subject matter expert for our… more