The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
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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