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Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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Job Description - Sr. Regulatory Affairs Manager (3279595) Sr. Regulatory Affairs Manager ( Job Number: 3279595 ) The Senior Regulatory Affairs Manager also develops and maintains familiarity with key health plan operational processes to inform our advocacy efforts.
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Director, Global Regulatory Affairs CMC-hybrid Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations.
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Bachelor’s Degree in environmental management, waste management, or environmental health with additional technical training desirable; three (3) to five (5) years of professional experience in code enforcement, environmental health policy development and regulatory affairs; or an equivalent combination of education and experience.
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Reporting to the Chief Medical Officer, the Senior Director of Regulatory Affairs will be responsible for the development and execution of Sails regulatory strategy and operations.
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The Senior Director, CMC Regulatory Affairs will be responsible for managing a team of experts responsible for regulatory CMC activities through all stages of the lifecycle for product in their portfolio.
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TheSenior Director, Commercialization and Development Counselwill be responsible for providing legal counsel and business advice to Commercial, Clinical, Medical and Pharmacovigilance leadership and the Marketing, Market Access, Regulatory Affairs, Medical Affairs and Drug Safety teams on relevant areas of law, policy, business opportunity, risk, and mitigation strategies.
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Experience in providing statistical programming support to early and late phase clinical trials, and regulatory submissions (NDA, MAA). Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc.
$164,000 - $205,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Engage with senior commercial leaders in a broad range of areas outside of market access such as sales, medical, regulatory, operations, finance, supply chain, manufacturing, pharmacovigilance, external affairs, and other functions.
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These activities will be performed in cross-functional collaboration with a range of partners throughout the organization, including the US Market Access, US Medical Affairs, Medical Outcomes Science Liaison (MOSL), Public Policy & Government Relations, and US Regulatory Affairs teams.
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The Program Leader will lead a cross-functional team across clinical operations, regulatory affairs, clinical pharmacology, biomarkers, CMC, non-clinical, and medical to deliver against the program strategy.
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Outside of the Platform, the Head will work with leaders from Biostatistics & Data Management, Global Regulatory Affairs, Clinical Pharmacology / Pharmacometrics, HEOR, Legal/Compliance, and others to achieve research and business objectives.
$262,100 - $436,800 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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The primary role of the Director, Regulatory Affairs - CMC is to create and/or manage contributions from others for CMC regulatory submission documents. This position reports directly to the Senior Director, Head of Regulatory Affairs - CMC. The Director, Regulatory Affairs - CMCwill be responsible and accountable for CMC submission documents while successfully up-holding the vision for the function and help mentoring junior team members.
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They will work with R&D, Quality, Manufacturing, Gene Therapy Team, Operations, Clinical and Regulatory Affairs, and Marketing/Sales, with the end goal of meeting performance, quality, and cost requirements, while optimizing time to market for company products.
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Bachelor's, Master's or PhD degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field. The Director/Vice President Regulatory affairs for iPSC derived cell therapies will manage the execution of global regulatory strategies for investigational and marketed cell and gene therapy products.
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regulatory affairs jobs Title: sr regulatory affairs associate in Lexington, MA
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