Many companies deal in goods and services that are subject to a variety of legal constraints. To avoid breaking the law, these companies frequently hire a regulatory affairs manager, a person who is responsible for keeping track of relevant laws and regulations and ensuring that the company follows them. A regulatory affairs manager is responsible for researching and monitoring laws and regulations, disseminating this information to others within the organization, conducting regulatory risk assessments, and acting as a liaison with government regulatory agencies.
While not all businesses deal in products or services that are subject to regulatory oversight, many do, especially if they manufacture goods or provide services that are subject to licensing or other types of legal compliance. For example, national regulatory agencies such as the Food and Drug Administration (FDA) in the United States or the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom often set standards for the manufacture of medical equipment. A regulatory affairs manager for a company that manufactures health-related products and equipment must be aware of not only the regulatory standards in their own country, but also the regulatory standards in other countries if the products are to be exported.
A regulatory affairs manager will also work within his company to ensure that employees are informed about regulatory issues. He usually creates procedures for notifying the organization when regulatory changes occur, and he may serve as a point of reference for various departments. When regulatory issues are in flux or in dispute, a regulatory affairs manager will frequently contact officials from the appropriate agencies to try to resolve the situation.
Regulatory affairs managers receive a wide range of training. Some regulatory affairs managers have law or library science degrees, the latter because regulatory affairs frequently necessitates extensive research and the use of proprietary databases. Because regulatory compliance often necessitates a thorough understanding of an industry as well as a company’s product line or services, it’s not uncommon for a regulatory affairs manager to have worked in other departments. After many years of learning about the company and industry, the employee may be given additional regulatory affairs training before being promoted to regulatory management.