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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 Associate Director, Regulatory Affairs reports to the Senior Director, Regulatory Affairs and executes clinical and preclinical regulatory strategies and activities.
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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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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 - CMC will 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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Acumen Pharmaceuticals is seeking a Director, CMC Regulatory, reporting to the Vice President, Regulatory Affairs, to lead the development, implementation, and execution of CMC regulatory strategy, including global submission strategy for investigational applications, clinical trial support, compliance, marketing application strategy, and CMC change management, ensuring compliance with global regulations (e.g., FDA, EMA, MHRA, HC, PMDA, CFDA, ANVISA.
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May serve as regulatory affairs representative to provide input on clinical trials and filing activities and to ensure that report systems are maintained and compliant. This is a role intended for a forward looking, creative and agile regulatory strategist able to anticipate and address the challenges involved in developing and registering oncology therapeutics/vaccines based on messenger RNA technology, an unprecedented new drug modality in the US and other global markets.
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Requirements: Master's degree in Regulatory Affairs, Engineering, Life Sciences, or closely related technical discipline (willing to accept foreign education equivalent) and five (5) years of experience as a Regulatory Affairs Specialist or experience executing the complete lifecycle of product registrations before national and international regulatory agencies, including documenting internal processes for quality control, and coordinating post-market surveillance and reporting activities.
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Ability to integrate public policy advocacy with public affairs, communications, business strategy and corporate development. Experience working in state government or leading policy or public affairs work for third-party organizations (e.g., lobbyist or running campaigns.
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The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products.
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Through a comprehensive understanding of the diagnostic and care landscape, the candidate will closely collaborate with the International Business Unit (IBU) marketing and medical teams, Government Affairs, and International Communication teams to execute, in partnership with the local affiliate teams, integrated solutions designed to remove obstacles to optimal patient pathways.
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Lead the global Regulatory Affairs (RA) team and provide organizational guidance and support to Thermo Fisher Scientific's Laboratory Plastic Essential (LPE) business within the Laboratory Product Group (LPG.
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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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Experience in Regulatory Affairs promotion and advertising; experience managing major regulatory filing(s) (e.g., launch advisory comment submission or responses to enforcement letters) or competitor complaints.
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BS with 8+ years of industry experience (or equivalent combination of education and experience) with at least 5+ years in regulatory affairs. Responsible for the development of regional regulatory operations that de-risk and accelerate the registration of innovative and established medicines for both US and OUS regulatory agencies.
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Minimum 2-4 years of experience in the pharmaceutical/biotechnology/life science industry, including at least 2 years of regulatory affairs CMC experience. The Manager, Regulatory Affairs CMC Development is responsible for implementation of the global regulatory CMC strategy for commercial programs.
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Title: regulatory affairs Company: Gritstone Oncology in Lexington, MA
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