Companies dealing with regulated goods and services employ a Regulatory Affairs Manager to ensure compliance with laws and regulations. They research and monitor laws, disseminate information, and liaise with regulatory agencies. Training can vary, but familiarity with the company’s industry is common.
Many companies trade goods and services subject to complex legal restrictions. In order not to break the law, these companies usually employ a Regulatory Affairs Manager, an employee who specializes in following the relevant laws and regulations and ensuring that the company 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 issues, and acting as a liaison with government regulatory agencies.
While not all companies deal with products or services that require regulatory control, many do, particularly if the company manufactures goods or provides services subject to licensing or other types of legal compliance. For example, standards for the production of medical devices are usually set 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 companies that manufacture health-related products and equipment must not only be aware of regulatory standards in their own country, but may also need to ensure that the company’s equipment meets standards in other countries for the products to be used. . exported.
A regulatory affairs manager will also work within your organization to ensure that employees are aware of regulatory affairs issues. He typically develops processes to notify the organization when regulatory changes arise and can act as a point of reference for different departments. In cases where regulatory issues are ongoing or in dispute, a regulatory affairs manager will usually contact officials from the appropriate agencies in an attempt to clarify the issues.
Training for regulatory affairs managers can vary greatly. Some regulatory affairs managers have an academic background in law or library science, the latter because regulatory affairs often requires a lot of research and the ability to use proprietary databases. As regulatory compliance often requires a strong familiarity with a company’s industry and line of products or services, it is not uncommon for a regulatory affairs manager to be someone who has worked in other areas of a company. After many years of learning about the company and the industry, the employee may receive additional training in regulatory affairs before assuming a regulatory management position.
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