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European Biopharmaceutical Review

Rules for Success

Over the past 40 years, the role of regulatory professionals has changed immensely. Factors such as the rapid pace of technological innovation, heightened global safety issues, and different and changing regulatory environments are just a few of the challenges that influence the regulatory landscape and, in turn, shape the profession.

In those years, some regulatory societies have seen their membership evolve as the dynamics of the profession have pivoted to meet regulatory and strategic demands. Membership has transformed from a collection of individuals from varied fields, tasked with the administrative aspects of a growing body of requirements, to a group of professionals who engage with the entire product lifecycles of their respective organisations. Regulatory teams link science, technology, and innovation with clinical needs and maintain a watchful eye on compliance and developments, policy, and good business practice.

This article discusses the evolving role of regulatory within the pharmaceutical industry, the importance of having a competent workforce, and how this profession can be a strategic driver of organisational success.

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Dr William Bridges joined the Regulatory Affairs Professionals Society as Vice President of Education and Professional Development in January 2017. In his 20 years of experience, he has designed instructional materials and curriculum, created a vision for education and training programmes, and developed competency-guided roadmaps for learners in the military, academia, government, and association spheres. He also holds a PhD in history from the University of Nebraska, US and has taught for the University of Nebraska, US, Towson University, US, and the American public university system.
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