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Manager, Regulatory Affairs
What Regulatory Affairs (NPHS Drug Manufacturing) contributes to Cardinal Health  Regulatory Affairs (NPHS Drug Manufacturing) is responsible for regulatory filings (such as abbreviated/new drug applications, drug master files, supplements, establishment registrations, and PDUFA/GDUFA fee payments) and compliance with regulatory agency requirements (such as annual reports, labeling requirements, regulatory aspects of change management, and participation in inspections if/as needed) regarding drug products, APIs, intermediates, and starting materials. In short, drug lifecycle management for an active portfolio of drugs, as well as filing applications for new drugs.   

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