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Regulatory Affairs Specialists


Requirements

Education and Training Requirements

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 computer 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, pharmacy, or science. 

Certification, Licensing, and Special Requirements

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. Many 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 the certification exam. Find information at https://www.raps.org/rac-credential/home.

Experience, Skills, and Personality Traits

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; 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.