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Two (2) years of progressively responsible experience in regulatory affairs, legislative affairs, or energy policy at an electric utility, regulatory agency, or legislative office.
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The Wounded Warrior Project (WWP) Government Affairs Deputy Director assists in the development and implementation of WWP’s public policy strategy to advance its legislative, regulatory, and advocacy priorities.
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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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This Regulatory Affairs Manager – Digital Health Technology will work on-site at our Alameda, CA location in the Diabetes Care Division. This Regulatory Affairs Manager – Digital Health Technology will provide support for the regulatory department to ensure efficient and compliant business processes and environment.
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Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations.
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The PGDx Regulatory Affairs and Quality Assurance Teams ensures the suitability, safety and effectiveness of next generation sequencing (NGS) medical devices that are developed, manufactured and distributed from our Baltimore, MD site.
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Rocket Pharma is seeking an accomplished and strategic Senior Director of Regulatory CMC to lead our Chemistry, Manufacturing, and Controls (CMC) regulatory affairs. The ideal candidate will possess extensive experience in CMC regulatory affairs, particularly in writing CMC sections for INDs, NDAs, BLAs, and MAAs, as well as strong leadership skills.
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Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams.
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Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions.
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Collaborate and work cross-functionally with Manufacturing, Regulatory Affairs, Assay Development, Finance, and Quality functions to ensure all activities are scheduled and executed on time in accordance with program timelines.
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Provide PV leadership for Jazz Pharmaceuticals Clinical Development including Clinical, Investigator Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence.
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We seek outstanding candidates with teaching experience in the following: industry experience in entrepreneurship, drug/ medical device development, data science, regulatory affairs, clinical and medical affairs, quality management, project management, finance, business operations, research and development, biometrics, health economics and outcomes research or manufacturing.
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7+ years of experience working with the state Legislature, the Executive Branch, municipal government officials, government relations, public policy, advocacy, government affairs, or campaigns. The Vice President, State Government Affairs will be part of the UHG External Affairs organization, responsible for working with colleagues across External Affairs and the Company to develop and implement strategies on the company's declared state government advocacy, growth, relationship and reputational priorities and overall business advancement initiatives with key state policymakers.
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This position is hybrid, and based in Santa Monica, CA and reports to the Executive Director, CMC Regulatory Affairs. The AD CMC Regulatory Affairs supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies.
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10 years of relevant experience with either government, prime government contractors, consulting firms, and/or NGO organizations related to national security, defense, information warfare, influence operations, foreign affairs, international development, and other relevant fields.
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regulatory affairs jobs Title: sr director Company: Sanofi
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