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With 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience. Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas.
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The Senior Associate, Regulatory Affairs is responsible for supporting applications under pre and post approval conditions. Under the direction of Regulatory Affairs management, participate in drug development from early stage development through final formulation, ensuring compliance with principles of Quality-by-Design, cGMP, and FDA rules and regulations.
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Prepares legal documents such as contracts, correspondence (e.g., to regulatory agencies), both independently and for review, approval, and use by Legal Affairs management. Acts as legal advisor for assigned corporate business and functional areas of the Daiichi Sankyo Oncology Business Unit and US Oncology Business Division of the Company (including, for example, Market Access, Sales, Marketing, Medical Affairs) as well as DSI employees performing Global roles in the United States (such as Global Marketing, Global Medical Affairs.
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Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs. The Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs.
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5+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on quality-of-life products preferred. The Contractor - Senior Manager, Regulatory Affairs - Quality of Life (QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory activities related to QOL initiatives.
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Ensures cross-functional execution of the pediatric segment strategy with US partners, including sales, brand marketing, customer operations, market access, medical affairs, policy, communications, Health Economics, regulatory, legal, and compliance.
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The US Regulatory Affairs Sr. Associate – Wellness is responsible for end-to-end regulatory activities for the Wellness portfolio, which is comprised of primarily dietary supplements.
$80,791 - $101,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials for an assigned product/therapeutic area in order to help ensure the Company’s objectives are met.
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In collaboration with the Director of US Customer Marketing, you will proactively engage and collaborate with a cross-functional team, which includes Brand Marketing, Sales, Market Access, Medical Affairs, Finance, Regulatory Affairs, Legal, Health Economics, Policy, I&T, Comms and Training in the development of a customer’s known and unknown needs, customer influence and journey maps, and the execution of the customer plans for the US market.
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Proclinical is seeking an (Associate) Director, Regulatory Affairs, Advertising & Promotion for a global pharmaceutical company with their location in New Jersey. (Associate) Director, US Regulatory Affairs, Advertising & Promotion - Permanent - NJ & MA.
$150Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Step into the realm of regulatory strategy and compliance as the Assistant Director/Director of Regulatory Affairs. Assistant Director/Director of Regulatory Affairs.
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The Associate Director/Director, Regulatory Affairs - GDP, provides essential support to the Senior Director in overseeing regulatory activities related to Quality of Life (QOL) initiatives on a regional and/or global scale.
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Liaise with Legal/Medical/Regulatory Affairs to support claim development and document key claims and their substantiation. Mentor the Associate Brand Manager to create and drive superior execution of go-to-market activation plans, bringing brand strategies to life across digital, advocacy, media, sampling, publications, conventions, and data analysis.
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