- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Lead , GI & Inflammation where ... you will define, develop, and lead global strategies to maximize global regulatory...project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types. +… more
- AbbVie (Waltham, MA)
- …Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead , Global Regulatory Strategy, is ... Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy… more
- 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 ... on development strategies, and deliver on associated regulatory activities + Lead the Global Regulatory Matrixed Team in defining and executing the … more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will define, ... develop and lead global strategies to maximize global ...reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types… more
- Takeda Pharmaceuticals (Boston, MA)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... empower you to shine? Join us as an Associate Director , Global Regulatory Project Management...**How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co-… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... GRA CMC where you will independently develop and lead the execution of regulatory CMC investigational,...regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking an Associate Director , Global Regulatory Affairs in Cambridge, MA with the ... the immunology and inflammation therapeutic franchise, serve as the Global and US Regulatory Strategic Lead...Advice; Lead the development of high level global regulatory supplemental biologic application sBLA strategy… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Management** + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. The Director , Global Labeling Strategy Lead is a key role… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory , Regulatory Operations, Drug Discovery Units, ... the best of my knowledge. **Job Description** **About the role:** **Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology and… more
- Merck (Boston, MA)
- … CMC Oversight + Lead the preparation and submission of high-quality regulatory CMC device content for global submissions, including IND, NDA, BLA, and ... **Job Description** The Executive Director , Device Quality & Regulatory will... regulatory guidelines and trends. + Collaborate with global regulatory teams to align strategies and… more
- Manulife (Boston, MA)
- …practices. By overseeing the end-to-end regulatory requirement process and managing national/ global regulatory impacts, you will play a critical part in ... As the Director of Regulatory Risk and ...Change Management, this role offers a unique opportunity to lead and ensure compliance with evolving regulatory … more
- Regeneron Pharmaceuticals (Cambridge, MA)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... role, a typical day might include the following:** + Provide interpretation of regulatory authorities' feedback, policies and guidelines. + Lead the development… more
- Sanofi Group (Cambridge, MA)
- …of patients around the world. **Medical Director ** **- Global Medical Evidence Generation** supports disease registries, post- regulatory authorization ... Immunology pipeline assets. The Medical Director will report directly to Global Medical Evidence Generation Lead , Next-Gen Immunology Franchise and will be… more
- Actalent (Boston, MA)
- …to both the technical team and Regulatory teams. Develop and implement global regulatory CMC strategies that maximize probability of success. + Support the ... to generate and refine the product development strategy. + Lead preparation of high-quality global clinical trial...Minimum of 5+ years of relevant experience in CMC Regulatory Affairs for biologics, including IND activity, global… more
- Sanofi Group (Cambridge, MA)
- ** Global Medical Director , Early Pipeline Respiratory, Global Medical Immunology** **About Sanofi** At Sanofi, we are committed to the growth of our people, ... world. **Job Responsibilities:** + The Early Pipeline Respiratory Medical Director reports to the Global Medical Head...direction of the Global Respiratory and Gastroenterology Global Medical Lead + This role will… more
- Black & Veatch (Burlington, MA)
- …diverse talents and perspectives to use. **The Opportunity** The ** Global Benefits Director ** will have the opportunity to: + Lead the strategic design, ... ** Global Benefits Director ** Date: Oct 22,...plans, administrators, consultants and systems and create recommendations to lead the organization to one unified global … more
- Takeda Pharmaceuticals (Boston, MA)
- …development of scientific communications strategy and deliverables, the **Associate Director , Scientific Communications Lead , Solid Tumors** proactively defines ... empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to...life sciences, and excellent project management skills. The Associate Director , Scientific Communications Lead , develops and implements… more
- Sanofi Group (Cambridge, MA)
- …gastrointestinal diseases. **Main Responsibilities:** The Early Pipeline Gastroenterology Associate Medical Director reports to the Global Medical Head of ... curate patient and scientific evidence and partner with commercial, regulatory , R&D, market access, and external affairs teams to...direction of the Global Respiratory and Gastroenterology Global Medical Lead This role will closely… more
- RTX Corporation (Andover, MA)
- …- Strategy and International, this position will serve as Raytheon's legal lead for supporting Raytheon's global operations and deployment activities. Raytheon ... global operations, governance issues, cross-border deployments, legal and regulatory compliance issues, and transactions, and experience guiding businesses to… more