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.
Job Summary The Regulatory Specialist is responsible for supporting the Regulatory Affairs (RA) department across several development projects and commercialization in various regions. Compiles, quality checks (QC), and executes complex regulatory submissions (worldwide) and maintenance of existing applications. Utilizes detailed, in-depth understanding of global regulations applicable to IPM products, conducts regulatory intelligence as necessary. Support regulatory submissions with preparation and editing of high-quality submission-level documents. Work with RA team members to provide comprehensive submission packages. Job Responsibilities To perform this job successfully, an
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