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 bachelors 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 masters 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.

Certification or Licensing

Regulatory affairs specialists may receive voluntary certification to demonstrate to employers that they have a achieved a high level of knowledge and skills in their profession. Several professional associations offer certification programs. For example, the Regulatory Affairs Professionals Society offers the regulatory affairs certification designation to candidates who have three to five years of regulatory experience and pass a certification exam. There are two RAC designations: Pharmaceuticals (RAC-Drugs) and Medical Devices (RAC-Devices). Find information at https://www.raps.org/certifications/rac. The National Society of Compliance Professionals and Compliance Certification Board also provide certification credentials.

Regulatory affairs specialists usually have prior regulatory experience, such as one to two years as regulatory affairs associates. Specialists must have strong knowledge of government regulations, laws, legal codes, and agency rules. They must be good communicators, able to read, understand, and share information about regulations and rules. Active listening skills are also important for working effectively with regulatory project teams, supervisors, customers, and others. Regulatory affairs specialists spend a great deal of time using computers to review data and prepare reports; as a result, strong technology skills are required. People who do best in this field are analytical thinkers who are honest and ethical, detail oriented, reliable and responsible, and have an adaptable and flexible attitude.