- 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)
- …pertaining to global and local labeling compliance and quality within Global Regulatory Affairs. + Partners with internal stakeholders and external CRO ... to the best of my knowledge. **Job Description** The Regulatory Affairs-Labeling, Associate Director is responsible for...partners such as Global Regulatory Compliance, Global Labeling,… more
- Takeda Pharmaceuticals (Boston, MA)
- …Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Independently ... Authorities, as required. + Proven ability to liaise with Regulatory Agencies, having served as lead in...international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug… 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 (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
- Sumitomo Pharma (Boston, MA)
- …experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the Global Regulatory Affairs (GRA) team based ... the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory... Lead , manage regional (United States and/or European) regulatory activities as part of a Global … more
- Sumitomo Pharma (Boston, MA)
- …, Regulatory Affairs** . The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as ... registration strategy of a project in collaboration with the Global Regulatory Leader (GRL). He/she is expected... Lead , manage regional (United States and/or European) regulatory activities as part of a Global … 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
- Takeda Pharmaceuticals (Cambridge, MA)
- …evidence generation needs; + Collaborates with cross-functional team members to define global evidentiary needs of key stakeholders ( Regulatory bodies, HCPs, ... of peri -and post-approval interventional and RWE prospective study design within Global Medical Evidence (GME) to support access needs. + Provides innovative… 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
- Norstella (Boston, MA)
- Sales Director , Regulatory Company: Citeline Location: Remote, United States Date Posted: Dec 20, 2024 Employment Type: Full Time Job ID: R-799 **Description** ... drug treatments, medical devices and what's new in the regulatory and commercial landscape. Relying on us to deliver...biotechnology and healthcare service providers, including the top 10 global pharma and CROs. Now, Citeline is proud to… 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: Dec 25,...plans, administrators, consultants and systems and create recommendations to lead the organization to one unified global … 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
- Sanofi Group (Cambridge, MA)
- …for chronic dermatologic, respiratory, and gastrointestinal diseases. **Position Summary** + The Global Medical Director of Dermatology, reports to the Global ... function serves as a key strategic partner with commercial, regulatory , clinical, and market access on therapeutic solutions to...works under the direction of the Dermatology and Rheumatology Global Medical Lead . + You will closely… more
- Organon & Co. (Boston, MA)
- …**The** **Position** **This position can be 100% remote in the US** The Director , Translational Medicine and Early Development (TMED) Lead will be responsible ... are sound, based on the most up-to-date literature and regulatory guidances and support the approved early development plans....for the execution (in conjunction with the TMED Operations Lead ) and reporting thereof. The Director will… more