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.
Objective The Regulatory Affairs Coordinator will provide various regulatory and administrative support for the clinical research programs. The position will assist with regulatory document preparation, editing of regulatory and clinical documents and provide general administrative support to the Clinical and Manufacturing teams. Regulatory Support Duties Assists in preparation and review of Clinical Trial Protocols, Study Reports, Investigator’s Brochures, etc. Assists in preparation of non-clinical (M 2.4, 2.6), (M 4) and clinical (M 2.5, 2.7) parts of the CTD dossier for INDs in the USA with subsequent submission of the regulatory documents to the eCTD publisher. Assists in the pre
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