- 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 (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
- 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
- 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
- Western Digital (Boston, MA)
- …will oversee and optimize our organization's payroll processes. As the Director of Global Payroll Services, you will lead and mentor the global payroll ... and ability to partner effectively across the organization. **Key Responsibilities:** . Lead global 20-person payroll team with regional managers for compliant… more
- Takeda Pharmaceuticals (Boston, MA)
- …of clinical trial and Pharmacovigilance methodologies including detailed comprehension of global regulatory requirements. + Good cross-cultural understanding and ... therapies to patients worldwide. Join Takeda as an Associate Director , Global Patient Safety Clinical Operations in...Clinical Development Program issues/risks in a proactive matter and lead discussions to mitigate them + Perform tasks of… more
- Olympus Corporation of the Americas (Westborough, MA)
- …an entity other than @Olympus.com, it is likely not legitimate._ **Job Description** The Director , Global Health Economics & Market Access is part of Health ... Market Access (HEMA) function and reports directly to Executive Director , Global Health Economics & Market Access....product stages and lifecycles. **Job Duties** + Serve as global and US regional lead for ESE/DU… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as an Executive Director , Global Program Leader (GPL) in our Cambridge office. At Takeda, we are ... regulatory approval as well as product launch and global patient access + have the ability to partner...through all job attributes defined at Takeda + May lead key business initiatives: including evaluating new opportunities and… more
- Takeda Pharmaceuticals (Boston, 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
- Takeda Pharmaceuticals (Boston, MA)
- …In strategic partnership with cross-functional stakeholders, the Associate Director , Global Medical Communications, Immunology will: + Lead the planning and ... to the best of my knowledge. **Job Description** **Objectives/Purpose** The Associate Director , Global Medical Communications, Immunology is a key strategic… more
- Takeda Pharmaceuticals (Boston, MA)
- …Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs. + Advanced knowledge of regulatory ... therapies to patients worldwide. Join Takeda as an Associate Director , Quantitative Clinical Pharmacology Lead in Cambridge,... interactions. + Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be… more