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.
Certara is hiring an Associate Director/Director, Global Submissions for our Synchrogenix division! The role can be based out of any US Certara office, or full time remote. Certara is the global leader in advancing modern, efficient drug development. We provide proven modeling & simulation, regulatory and real-world value assessment software platforms and services. In partnership with our clients, we help reduce clinical trial burden, accelerate regulatory approval and increase patient access to medicines. At Certara, we accelerate medicines to patients by partnering with life science innovators. In the past 6 years, over 90% of companies that received new drug approvals by
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