Regulatory professionals should continuously expand their knowledge and advance in their understanding of compliance so as to grow and face the many unpredictable challenges in their daily regulatory affairs assignments.
A general science or engineering background is essential in the
Regulatory affairs field. Good regulatory skills include awareness and understanding of technical details, and an analytical mind that evaluates situations in a logical manner. This entails providing critical reviews, listening attentively, observing keenly, asking leading questions and presenting good ideas and effective strategies.
The
Regulatory affairs programs offered by many prestigious universities is the best starting point for regulatory enthusiasts. Most individuals enroll for regulatory affairs programs as working professionals - approximately two-thirds come from the pharmaceutical, biologics, and medical device industries, while the remaining third are employed in contract research organizations and other scientific organizations.
The
Regulatory affairs programs offered by American universities teach not only the basics of regulatory requirements but also how FDA interprets and enforce its regulations. With the scope of the courses as well as the ability to extend the presentation of these courses online, these programs offer individuals an opportunity to gain additional education in the regulatory aspects of health care research and development, regardless of their geographic location.