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Specialist/Senior Specialist-GxP QA - Regulatory Affairs
DescriptionThis position will join Cincinnati Children's Hospital's research administration, within the Office of Research Compliance and Regulatory Affairs, specifically providing regulatory support and quality assurance oversight to the Cincinnati Children's Hospital's Translational Core Labs Cell & Gene Therapy manufacturing operations to ensure compliance with FDA Good Manufacturing Practices and Good Tissue Practices. The Translational Core Labs manufactures products suitable for early phase clinical trials for both academic and pharmaceutical sponsors.REPRESENTATIVE RESPONSIBILITIESRegulatory Knowledge & OversightIndependently interpret and analyze the concepts and principles of specific elements of federal and state law


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