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.
We are currently seeking a Sr. Manager, Regulatory who will be responsible for performing a wide variety of activities pertaining to assuring compliance with applicable regulatory requirements, including but not limited to: managing the site regulatory submissions, regulatory audits, documentation review, and preparing regulatory documentation (CTD, IND, NDA) for clients. *The Sr. Manger, Regulatory is an exciting, fully remote opportunity! Responsibilities: Serves as the regulatory affairs subject matter expert (SME) for the company. Collaborates with, and advises clients and external stakeholders on the development of regulatory strategy for submission of new product applications and chang
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