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.
Overview: This position is responsible for the preparation and maintenance of domestic and international regulatory filings to meet corporate objectives, and for the timely completion of other assigned activities related to regulatory support activities worldwide. Responsibilities: Prepare high quality international and domestic regulatory filings to established timelines Represent Regulatory Affairs department in assigned project meetings for new product development and/or sustaining projects, as assigned Review and approve document change orders and prepare letters-to-file Update departmental procedures, as required Ensure applicable domestic and international regulations are met Maintain up-to-date knowledge on d
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