- Merck & Co. (Boston, MA)
- …developing and executing integrated development plans that align clinical, medical affairs , commercial, manufacturing, regulatory, analytical, and ... DescriptionOur Clinical Research and Pharmacovigilance team pushes the boundaries of global healthcare through research and innovation. Through clinical trials and… more
- FleishmanHillard (Boston, MA)
- **Summary:** FleishmanHillard is seeking a seasoned professional to lead and build a high-performing earned media relations function for a major life sciences ... demonstrate a profound interest in furthering our DE&I goals. **Key Components:** + Lead a team of earned media experts to drive tangible results: increase positive… more
- CSL Behring (Waltham, MA)
- …and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA ... from PST, CDT, SMT and related delivery teams. May lead discussion at Global Regulatory Forum (GRF)...continually refine ways in which products can address unmet medical needs and help patients lead full… 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
- Sanofi Group (Framingham, MA)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is...ensures appropriate communication, resolution and/or escalation as needed + Lead global filing and lifecycle management activities… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown, NJ **About the Job** Are you ready to shape the future of ... strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role offers the… 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)
- …life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead will support ... + Regulatory advisor as the "R" in the core Medical , Legal, Regulatory review functions of the Commercial Material...review, approval, and implementation + Product or project business lead for global CMRP at Takeda +… 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. (Boston, MA)
- …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
- Takeda Pharmaceuticals (Boston, MA)
- …and/or post-approval strategies for assigned products as GRA CMC Product Lead . + Represents and contributes to Regulatory, Pharmaceutical Development, and Commercial ... - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a...standards. + When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (eg,… 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 (Boston, MA)
- …+ 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 (Boston, MA)
- 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 (Boston, MA)
- …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
