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Executive Office support: serves as Chief of Staff to the VP, Head of Alexion Regulatory Affairs, supporting internal and external engagement and managing activities as part of the function’s Executive Office.
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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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Regulatory Affairs Manager *PC Regulatory Affairs - Waltham MAAt Miltenyi Biotec, 3, employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies.
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Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs for Associate Director. Reporting directly to the Senior Director CMC of Regulatory Affairs, the (Associate) Director of Regulatory CMC will be responsible for the development of regulatory CMC submissions.
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On-going training and attention to international affairs are essential. Under the supervision of the Sr. Director Global Export Compliance, this individual will support the Export Control Department in the evaluation and analysis of U.S. and applicable export control and economic sanctions laws and regulations, know your customer (KYC) compliance requirements, and deep transactional due diligence.
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The Scientific Affairs Manager is a key member of the content development team who utilizes their combined skills as a scientific medical writer, educational design innovator, and grant development specialist to conduct a turnkey process that includes educational grant development, followed by content development for awarded grants.
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Work closely with the Head of Scientific Affairs & Strategic Partnerships and Scientific Affairs team to produce rapid, thoughtful responses to content-related requests from across Pfizer Oncology (CSO, Medical strategy, BoD, Investor Relations, colleagues, etc.
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You've acquired a minimum of 7 years' Regulatory Affairs experience within FDA regulated, complex Medical Device/Software (SiMD/SaMD) environments, including leadership/guidance on global regulatory strategy for 510K's, CE Marking per MDD, EU MDR (updating Technical Files), Worldwide product registrations, Design Dossiers, PMA, clinical evaluations, Post Market Surveillance and reviewing Marketing Communication materials for promotional purposes.
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Bluebird bio is seeking an accomplished and adaptable Director Medical Affairs to join the medical affairs team, focused on our gene therapy programs for Sickle Cell, Beta Thalassemia, and CALD. You will be joining a passionate and committed flock, flying closely with medical birds as well as the cross functional teams.
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Support Danaher Diagnostic Operating Company Medical and Scientific Affairs and Government Affairs organizations on their strategy so that it maximizes patient impact at scale. Prior roles in industry Medical and Scientific Affairs and/or Government Affairs functions a plus.
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The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager's gene therapy products.
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The Senior Regulatory Affairs Manager also develops and maintains familiarity with key health plan operational processes to inform our advocacy efforts. The Senior Regulatory Affairs Manager, in collaboration with the Director, LRAC, will lead the federal advocacy efforts through trade associations, including America's Health Insurance Plans (AHIP.
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Reporting to the Associate Dean of Students in the Division of Student Affairs, the inaugural Director of LGBTQIA+ Student Resource Center ("Center") will be charged with laying the foundation for and ensuring the immediate and ongoing success of the new Center at Boston University.
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The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRCMC) Devices and Combination Products will be responsible for leading, developing, and implementing global CMC regulatory strategy related to Alexion's drug/device portfolio, in vitro diagnostics and clinical decision software leading to successful registration and life-cycle management of unique and technologically complex products.
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The senior leader, Cardiovascular Medical Affairs will have a strong understanding of all phases of product development, including preclinical development, clinical trial management, market preparation and launch readiness, post-launch marketing, post-approval studies, regulatory affairs, GCP and manufacturing compliance.
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affairs job Title: sr regulatory affairs associate in Cambridge, MA
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