- Merck & Co. (Boston, MA)
- …discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide clinical ... environment of mutual respect, encouragement, and teamwork. As part of the global team, you will collaborate with talented and dedicated colleagues in Translational… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Learn more about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** The Global Lead Medical Affairs - Gastroenterology ... role requires the application of prior clinical knowledge and medical training to lead internal stakeholders within...+ Deep knowledge of the Gastroenterology therapeutic area and global understanding of medical affairs ,… more
- Takeda Pharmaceuticals (Boston, MA)
- …career grounded in purpose and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Scientific ... Hematology to optimize department resources and evaluate trends in medical publications, and lead and/or participate in...needed, provide medical and scientific review of Global Medical Affairs Oncology materials… more
- Takeda Pharmaceuticals (Boston, MA)
- … medical /scientific director will provide scientific & team leadership, guidance across global medical affairs activities for advanced stage molecules ... will work in a multifunctional, matrix organization with other medical affairs functions ( global ...will contribute:** + Provide scientific/clinical expertise and leadership to lead development of the asset specific medical … more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …emerging Neurology portfolio). This role will report to the Sr. Director, Global Medical Affairs , Franchise Lead CNS Early Assets. Assets under this ... experienced Medical Director of CNS Early Assets, Global Medical Affairs , responsible for... Lead CNS Early Assets. **Position Summary:** The Medical Director, Global Medical … more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs , Neuroscience is responsible for developing innovative ... on cross-functional Global Program Teams. The Senior Director also will lead discussions of regulatory strategy with senior leadership of the TAU and where… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA/ Waltham, MA/ Morristown, NJ **About the Job** Are you ready to shape the ... in helping our teams accelerate progress. As GRA CMC lead within our team, you'll have the opportunity to...the miracles of science to improve people's lives. The Global Regulatory Affairs (GRA) CMC & Device… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs , Neuroscience is responsible for developing innovative ... established andbuilding appropriate regulatory strategy. + Participates in cross-functionalinitiativeswithin Global Regulatory Affairs and Takeda R&D. **How you… more
- Takeda Pharmaceuticals (Boston, MA)
- …The Director will lead all submission types. + Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively ... regulatory reviewer in due diligence for licensing opportunities. + Partner with global market access colleagues to Lead interactions with joint… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **Job Title:** Associate Director - Analytics, Global Regulatory Affairs **Role Purpose:** Strategic and operational oversight ... of custom analytics deliveries from Global Regulatory Affairs involving Business Intelligence solutions...layer and custom analytics capabilities in alignment with the Global Regulatory Analytics lead . + Working with… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead . Translates complex pertinent global requirements and ... prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL). - Identifies the need and obtains… more
- Takeda Pharmaceuticals (Boston, MA)
- …**About the role:** The **Head of Ethics & Compliance (E&C) for PDT R&D and Medical Affairs ** at the senior director level is a senior leader responsible for ... managing the E&C program across PDT R&D and Medical Affairs , and driving continuous improvement aligned...audits; and delivering E&C training. The role also supports global initiatives, digital ethics, and data privacy efforts, while… more
- Danaher Corporation (Boston, MA)
- …oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work including in support of CDx trials and ... Biopharma sector. This position reports to the Director, Regulatory Affairs and is part of the Global ...this role, you will have the opportunity to: + Lead regulatory strategy and execution for external partnerships and… more
- Sumitomo Pharma (Providence, RI)
- …+ Provide strategic and operational leadership to the Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of advertising and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply experienced… more
- Sumitomo Pharma (Providence, RI)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... motivated, and experienced individual for the position of Vice President, Regulatory Affairs , Biopharma R&D. This position leads the Regulatory Affairs for… more
- Sumitomo Pharma (Providence, RI)
- …Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily ... registration strategy of the product + Supports the global regulatory lead (GRL) and the CMC...urgency and perseverance to achieve results + Understanding of medical terminology, and FDA and ICH regulations/guidance documents specific… more
- Rhythm Pharmaceuticals (Boston, MA)
- … Regulatory Affairs . Responsibilities and Duties + Act as the Global Regulatory Lead on multi-disciplinary project teams and provide strategic regulatory ... Company Overview Rhythm is a global , commercial-stage biopharmaceutical company committed to transforming the...barriers, together. Opportunity Overview In the Associate Director, Regulatory Affairs role, you will be responsible for ensuring the… more
- Sumitomo Pharma (Providence, RI)
- …position of **Director Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...(GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory strategy from… more
- Medtronic (Mansfield, MA)
- …(https://www3.benefitsolver.com/benefits/BenefitSolverView?page\_name=signon&co\_num=30601&co\_affid=medtronic) **About Medtronic** We lead global healthcare ... **Nice to Have: Preferred Qualifications** + 7+ years of medical device regulatory affairs with roles showing...for Employers and the California Fair Chance Act. We lead global healthcare technology and boldly attack… more
- Bausch + Lomb (Providence, RI)
- …to continue leading the advancement of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for development programs and ... Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the… more
