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What does a Regulatory Affairs Manager do?

A Regulatory Affairs Manager navigates the complex world of regulations, ensuring a company's compliance with laws and guidelines. They liaise between organizations and regulatory authorities, managing submissions, inspections, and audits. How does their role impact the success of a business? Let's delve deeper.
Lainie Petersen
Lainie Petersen

Many businesses trade in goods and services that are subject to complex legal restrictions. In order not to run afoul of the law, these businesses often employ a regulatory affairs manager, an employee who specializes in keeping track of pertinent laws and regulations and ensures the business remains in compliance with these rules. A regulatory affairs manager typically takes responsibility for researching and monitoring laws and regulations, disseminating this information to others within the organization, reviewing the organization for regulatory problems, and acting as a liaison with government regulatory agencies.

While not all businesses deal in products or services that require regulatory scrutiny, many do, particularly if the business manufactures goods or provides services that are subject to licensing or other types of legal compliance. For example, standards for the production of medical equipment are often determined by a national regulatory agency, 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. A regulatory affairs manager for a businesses that manufacture health-related products and equipment must not only be aware of the regulatory standards in their own country, but may also need to ensure the business's equipment meets the standards in other countries if the products are to be exported.

A regulatory affairs manager in a meeting.
A regulatory affairs manager in a meeting.

A regulatory affairs manager will also work within his organization to ensure that employees are aware of regulatory affairs issues. He typically develops processes for notifying the organization when regulatory changes arise and may act as a reference point for different departments. In cases where regulatory issues are in flux or in dispute, a regulatory affairs manager often contacts officials of the appropriate agencies in an attempt to clarify matters.

The training for regulatory affairs managers can vary widely. Some regulatory affairs managers have academic backgrounds in law or library science, the latter because regulatory affairs often requires a great deal of research and the ability to use proprietary databases. Because regulatory compliance often requires a strong familiarity with an industry and a company's product line or services, it is not unusual for a regulatory affairs manager be someone who worked in other areas of a business. After many years of learning about the company and industry, the employee may be given additional training in regulatory affairs before assuming a regulatory management position.

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    • A regulatory affairs manager in a meeting.
      By: pressmaster
      A regulatory affairs manager in a meeting.