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.
Manages a large, regional and/or global team of staff and managers within the department and provides innovative solutions including regulatory expertise and client interface to provide strategic regulatory intelligence and guidance for product development from preclinical through registration and product optimization. Manages projects and participates in strategic initiatives. Acts as liaison with internal and external clients in the provision and marketing of regulator Essential Functions: Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations. Approves cour
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