Regulatory Affairs Specialists

High School

Take classes in math, science, government, social studies, and business. Strong communication skills are essential in the regulatory affairs field so be sure to take English, writing, and public speech classes. Also take computer science classes as knowledge of various software programs is important.

Postsecondary Education

Most regulatory affairs specialists have a bachelor's degree. The degrees vary in this profession and may be in areas such as business, economics, engineering, clinical science, public health, or even liberal arts. Employers prefer to hire managers who have advanced knowledge of regulatory affairs, which can be attained through a master's degree program. In addition, many regulatory affairs managers have previous work experience and training in areas such as business, engineering, marketing, pharmaceuticals, or science.

Certification

Undergraduate and graduate certificate programs in regulatory affairs are offered by many colleges and universities. For example, Kansas State University offers regulatory affairs in animal health graduate certificate. To earn the certificate, students must complete the following courses: Regulatory Aspects of Drug and Vaccine Development in the Animal Health Industry; Strategies in Pre-Clinical and Clinical Research for Regulatory Affairs in Animal Science; Strategies in the Stewardship of Licensed Pharmaceuticals and Biologics in Animal Health; Regulatory Development of Animal Pharmaceuticals-Food & Drug Administration; Regulatory Development of Animal Pesticides-Environmental Protection Agency; Regulatory Development of Animal Biologicals and Diagnostics-U.S. Department of Agriculture; Special Topics: Regulatory Affairs in Animal Health; and Introduction to Statistical Methods for the Sciences. Certificate programs typically last six months to a year and are available in online, in-person, and hybrid formats. Contact schools in your area for information about available programs.

In addition, the Regulatory Affairs Professionals Society offers a certificate in effective communication. Visit https://www.raps.org/education/e-learning/certificate-in-effective-communication to learn more. The Regulatory Affairs Professionals Society offers certificate programs in medical devices and pharmaceuticals and other areas. Visit https://www.raps.org/education/online-university-certificates for more information.

Other Education or Training

Professional associations (e.g., National Society of Compliance Professionals, Regulatory Affairs Professionals Society, Society of Corporate Compliance and Ethics, The Organisation for Professionals in Regulatory Affairs) and colleges and universities offer continuing education seminars, webinars, and other learning opportunities. Contact these organizations for more information.