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Knowledge and experience in clinical and CMC regulatory affairs for pre-licensed and clinical RA for licensed biologic product or vaccine. As a Director, Regulatory Affairs, Vaccines you will e nsure the development and execution of the appropriate Regulatory strategy(ies) for assigned US asset(s), across all stages of the product life cycle and consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP.
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Jobs in Virology by ASV - Clinical Regulatory and Operations Specialist Clinical Regulatory and Operations Specialist National Institute of Allergy and Infectious Disease Tweet Apply Bookmark Report Categories: Other.
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Collaborate cross-departmentally - including with brand functions (e.g., medical communications, marketing, regulatory, clinical solutions, labs) and other functions (e.g., contracting, privacy, HR, IT) to deliver strategic and practical legal support as a trusted advisor on regulatory compliance and related disciplines.
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Job Summary:The Senior Associate is responsible for performing analysis, examination, review, assessment, and testing in a wide variety of client engagements at the direction of the project manager.
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They are seeking a Regulatory Affairs Manager for their Medical Centers in in Bethesda, Maryland. Job Title: Regulatory Affairs Manager 317147. This position will lead the Regulatory Affairs office and coordinate the activities related to the performance and compliance of all research projects at the Military Medical Center and its satellites and affiliates.
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Detect federal, state, and local regulatory developments impacting our business and engage stakeholders to ensure appropriate risk management strategies. Anti-bribery / anti-corruption laws (e.g., Foreign Corrupt Practices Act.
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Regulatory Affairs: Demonstrated understanding and implementation of Nuclear Regulatory Commission (NRC), Canadian Nuclear Safety Commission (CNSC) regulatory processes, the Office for Nuclear Regulation (UK) or other jurisdictional agencies and authorities.
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Leads the Regulatory Affairs office and supervises the protocol coordinators, technical writers and other regulatory staff. Prepares and maintains accurate copy of the principal investigator's manual and regulatory binders.
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Deep understanding of the US regulatory environment, the Food, Drug and Cosmetic Act and latest regulations and guidance’s with sound knowledge of intelligence tools and methods; preference will be given to candidates with experience supporting vaccines and infectious disease products, and experience across a number of disciplines including Pharmacovigilance, Quality, and Clinical Development.
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What you'll do:Lead a Global Regulatory Strategy Team (GRST) of GRLs within the franchise, contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team.
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The role holder will report to the Director, Medical Writing and will interact with the regulatory, preclinical, clinical, translational medicine, biometrics, pharmacovigilance, PK/PD, and medical affairs groups working across functions to provide writing support of documents.
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You will have a strong understanding of regulatory compliance strategy and the processes required to determine relevant compliance requirements to test, certify, and enable market access for Intellian products.
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Title: Regulatory Affairs Manager. Minimum of 3-5years of experience in operational regulatory affairs within the biotech, preferably in oncology. Develop and implement regulatory strategies to support the development and commercialization of oncology products.
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The ideal candidate will have (10+) years of experience in regulatory affairs, with at least 5 years in a leadership role, for in vitro diagnostic (IVD) companies. - Deep knowledge of regulatory requirements for IVD products, including FDA regulations (e.g., 510(k), PMA), EU IVDR, and other relevant international regulations.
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MPF Federal is seeking a Regulatory Data Specialist for our project located in White Oak, VA. Regulatory Data Specialist. Apply regulatory standards and prepare data for output to a variety of printed and electronic media.
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Title: regulatory Company: Clarivate Plc in Rockville, MD
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