- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs , Neuroscience is responsible ... andbuilding appropriate regulatory strategy. + Participates in cross-functionalinitiativeswithin Global Regulatory Affairs and Takeda R&D. **How… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead, GRAD Oncology. You will provide ... **How you will contribute:** + Defines, develops, and leads global strategies to maximize global regulatory...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the ... implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- AbbVie (Waltham, MA)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director Regulatory Affairs Global Regulatory ... maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and… more
- Takeda Pharmaceuticals (Boston, MA)
- … strategy and coordinating life cycle activities across the portfolio of PDT products. The Global Regulatory Lead, Director , in PDT R&D: + Serves as the ... US FDA and provides support for regional and local regulatory affairs teams for interactions with international...and/or other regional counterparts in compiling global regulatory strategies and works cross-functionally with RA … more
- Takeda Pharmaceuticals (Boston, MA)
- …understands probabilities of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices… 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 ... regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and...a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (eg, Growth… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **Objective / Purpose:** + Defines, develops and leads global strategies to maximize global regulatory success towards ... + Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of … more
- Rhythm Pharmaceuticals (Boston, MA)
- …commercialization and life cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs . Responsibilities and Duties ... to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you...execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will… more
- Bristol Myers Squibb (Cambridge, MA)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director , Global Regulatory Strategy, Neuroscience** **Position ... Summary:** The selected candidate will have leadership responsibility for global regulatory strategy within a development team...PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry.… more
- ThermoFisher Scientific (Waltham, MA)
- …significant contributions to the world. **Discover Impactful Work:** The Director of Regulatory Affairs ( RA ) is responsible for owning the regulatory ... submissions to support the commercialization of these products. The RA Director is able to combine knowledge...Q& RA system efficiencies to meet customer and global regulatory standards + Reviews and approves… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …might look like: + Responsible for the strategic company guidance on FDA and global regulatory requirements ( affairs and CMC) for investigational and ... this key leadership role, you will build and oversee Global Regulatory Science and Regulatory ...position you will build and lead a cell medicine regulatory affairs team and provide regulatory… more
- Bristol Myers Squibb (Cambridge, MA)
- …more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... + Ensure global development plans will meet global regulatory requirements by soliciting and integrating...with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience… more
- Takeda Pharmaceuticals (Boston, MA)
- … vaccine programs in various stages of development + Represents the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams to ensure that ... product developmentprogramspreferred + Sound understanding of scientific principles and regulatory CMC requirements relevant to global vaccine development,… more
- Takeda Pharmaceuticals (Boston, MA)
- …with applicable regulatory requirements. Serve as the expert for device labeling on the global Regulatory Affairs ( RA ) Sub team and Global ... to bring life-changing therapies to patients worldwide. As Associate Director , Global Labeling Devices, you will be...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more
- Chewy (Boston, MA)
- …and competitive regulatory intelligence, while ensuring compliance with global regulatory frameworks, including EU feed/food regulations, Canadian CFIA ... differentiator. **What You'll Need:** + Bachelor's or Master's degree in Regulatory Affairs , Food Science, Animal Nutrition, Veterinary Science, Business,… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and real-world evidence, US and global commercial teams, market access, and regulatory affairs , to ensure integrated global strategies and cohesive ... experienced Medical Director of CNS Early Assets, Global Medical Affairs , responsible for certain assets...or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/ RA ) ... global and regional levels. + Ensure the appropriate global regulatory requirements, are considered as part...preferred. + Minimum of 15 year of directly related Regulatory Affairs experience; preferably a minimum of… more
- Sanofi Group (Cambridge, MA)
- …decision-making. The Medical Director will collaborate with internal experts from Global and Local Medical, Clinical Development, and Regulatory teams to ... **Job title** : Global Medical Director , Evidence Generation -...with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial… more
- Sanofi Group (Cambridge, MA)
- …the IEGP. The Medical Director will collaborate with internal experts from Global and Local Medical, Clinical Development, and Regulatory teams to develop, ... **Job title** : Global Medical Director , Evidence Generation -...with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial… more