Directors of regulatory affairs manage a company’s regulatory responsibilities and anticipate challenges. They communicate with regulatory agencies, craft regulatory strategies, obtain necessary licenses, and supervise project teams. The job’s practicalities depend on the company’s size and scope.
A director of regulatory affairs is a professional involved in handling regulatory matters. While governments typically have the responsibility for carrying out regulatory work, directors of regulatory affairs are not always found within government. Within a wide range of companies across diverse industries, directors of regulatory affairs hold positions that effectively manage all of the company’s regulatory responsibilities and who proactively anticipate regulatory-related challenges in the countries in which the company operates.
A director of regulatory affairs working for a US company might, for example, be the “important person” to communicate with the US Food and Drug Administration. This regulatory agency is the main regulator for many consumer goods. The director of regulatory affairs can read and respond to letters from the FDA, including any “warning letters” about unapproved activities or products. The FDA can also contribute to product development by providing feedback on future planned products.
Many companies look to the Director of Regulatory Affairs to craft an overall regulatory strategy that anticipates and prevents issues related to non-compliance with any type of environmental or consumer legislation. The Director of Regulatory Affairs may be responsible for obtaining the necessary licenses for all projects and products. This professional will likely spend a lot of time reading documents, as many of a given company’s regulatory requirements rely on evidence and “as directed” submissions, where the language of a submission can determine outcomes.
Teams working on regulatory-related research may also be advised or supervised by the Director of Regulatory Affairs. This may include products that have not yet been approved by the FDA or that have been flagged for some other reason. These project teams can report to the Director of AR as a way to ensure that the appropriate leadership is in the loop to quickly advance new regulatory benefits. In general, the director of regulatory affairs will communicate within a broad area of a company and beyond with regulators and others outside the company.
The practicalities of a regulatory affairs director’s job will have a lot to do with the scope and size of a company. Looking at the company’s operations will tell outsiders a lot about how many trips a professional can take and what their expense account might look like. A leader or director of regulatory affairs at a larger or multinational company may have much more regulatory learning to understand how agencies function in foreign nations or regions, for example Asia, the Middle East or the European Union.
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