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.
Essential Duties and ResponsibilitiesNothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. With supervision, author and compile regulatory submissions in accordance with applicable ICH, CFR, and FDA guidance within specified timelines. This includes but is not limited to ANDA, PAS, CBE and Annual report submissions. Compile high-quality submissions in eCTD format in compliance with applicable regulations and FDA guidance employing use of submission publishing tools and software Participate in meetings and interact with members of the project team and sub-teams to drive submission timelines and determine risks to filing, escalating to man
This job listing is no longer active.
Check the left side of the screen for similar opportunities.