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.
Our Regulatory Affairs team brings essential generic quality medicines to our hospital members in the United States by providing CMC Regulatory leadership and establishing Civica’s Regulatory Affairs systems and processes. The Manager, Regulatory Affairs CMC: Provides CMC regulatory support for development programs and marketed products. Develops product CMC regulatory strategy for essential generic medicines and obtains shortest time to approval by regulatory agencies. Prepares and compiles new ANDAs, Amendments, Supplements, Annual Reports, and other regulatory filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met. Critically reviews documentation intended for sub
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