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The Executive Director, Regulatory Affairs will develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease ensuring fast to market global product registrations, product promotion, maintenance of products and processes in regulatory compliance with local regulations.
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Serve as a CMC strategist and project leader for projects/programs, providing regulatory assessments and developing regulatory strategies with input from the Executive Director Regulatory Affairs CMC.
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An advanced clinical degree (MD, DO, PhD, PharmD) and a minimum of 3 years in medical affairs or a related field. We are looking for a dynamic Director of Medical Affairs with a passion for medical communication and supporting scientific partnerships.
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Reporting to the Chief Medical Officer, the Senior Manager of Regulatory Affairs will be responsible for the development and execution of Sails regulatory operations and the planning, managing and tracking of regulatory submissions.
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Accomplished policy advocacy professional with at least 15 years of experience in public affairs (government affairs and/or policy). Lead development and implementation of global policy advocacy strategy on key global policy topics including engagement with multilateral institutions, international trade association engagement, and LOCs in close collaboration with Takeda’s Enterprise Public Affairs Leadership Team (EPALT.
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Pharmacy Postdoctoral Fellow – Medical Affairs Post-Doctoral PharmD Fellowship with Vertex Pharmaceuticals & Northeastern University for 2025-2027 (2 Years). In partnership with Northeastern University, Vertex Pharmaceuticals is offering a two-year Medical Affairs PharmD fellowship based in Boston, MA.
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Additionally, the VP, Regulatory Affairs and Quality will be responsible for hiring a Director, Regulatory Operations, to report to them. The Vice President, Regulatory Affairs and Quality will work collaboratively with colleagues across the company, and with outside partners, to design and execute global registrations strategies for all Xilio products, including initial regulatory efforts on pipeline programs.
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The Regulatory Affairs Specialist (RAS) positions are critical to successfully achieving ongoing clinical research expansion and regulatory compliance at DFCI. The Regulatory Affairs Specialist (RAS) positions provides advanced expertise and regulatory support to 600+ investigators and research staff members at DFCI, focusing on standards and techniques for performing job functions typical in the development and/or conduct of FDA regulated research from an operational and regulatory compliance perspective.
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The Regulatory Affairs Project Manager is an experienced project manager who works closely with the Global Regulatory Affairs, Regulatory Operations, and cross-functional teams to facilitate timely submission of high-quality data packages to US and international health authorities.
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The Associate Director will be accountable to the GRL and Global Regulatory Science Precision Medicine Head for development of appropriate regional Precision Medicine and Digital Health regulatory strategy(s) and their timely delivery.
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Dragonfly Therapeutics is seeking a Head of Regulatory Affairs, title commensurate with experience, and reporting directly to the COO, to lead our Regulatory Affairs organization. Leads, participates and contributes to initiatives and activities to help build a robust high performing regulatory affairs organization including operational excellence for effective and efficient execution.
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Work extensively with Alexion leaders across multiple departments including Early and Late R&D, RWE Generation, Global and In-Country Medical Affairs, Commercial, Public Affairs, Patient Advocacy, Market Access, and Clinical Operations to optimize Alexion interactions with the scientific societies and identify expanded areas for collaboration.
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The Associate Director, Public Affairs will serve as a critical Policy & Advocacy team member with responsibility for relations and collaboration with City and State legislators and regulators who make legislative, regulatory policy, and public policy decisions.
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Manage Information Technology applications within Student Affairs, including StarRez (Housing), ARMS (Police), ARMS (Athletics), Campus Groups, ISSM, iModules (with Advancement), Medicat, Advocate (CARE), RAVE, and Titanium.
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As a pivotal leader within the Division of Student Affairs, the Director of Residence Life reports to the Senior Associate Dean of Students and oversees a large and multifaceted residential program.
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Title: affairs Company: Gritstone Oncology in Waltham, MA
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