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What does a Regulatory Affairs Director do?

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  • Written By: A. Leverkuhn
  • Edited By: Andrew Jones
  • Last Modified Date: 17 November 2016
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A regulatory affairs director is a professional involved in dealing with regulatory issues. Although governments typically have the responsibility of conducting regulatory work, regulatory affairs directors are not always found in government. Within a wide range of companies in many different industries, regulatory affairs directors will be in job roles that effectively manage all of the firm’s regulatory responsibilities, and which proactively anticipate challenges related to regulation in the countries in which the business operates.

A regulatory affairs director working for an American company may, for example, be the “point person” for communicating with the U.S. Food and Drug Administration. This regulatory agency is the prime regulator for many consumer goods. The regulatory affairs director might engage in reading and responding to letters from the FDA, including any “warning letters” about unapproved activities or products. The FDA can also contribute to product development by offering feedback on planned future products.

Many companies expect their regulatory affairs director to craft an overall regulatory strategy that foresees and avoids problems related to non-compliance with any kind of environmental or consumer law. The regulatory affairs director may be responsible for obtaining necessary licenses for all projects and products. This professional will likely spend a lot of time reading over documents, since much of the regulatory requirements for a given firm rely on evidence and submissions “as stated” where the language of a submission can determine outcomes.

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Teams that are working on research related to regulation, might also be advised or overseen by the regulatory affairs director. This might include products that have not yet been approved by the FDA, or which have been flagged for some other reason. These project teams may report to the RA director as a way to make sure that the appropriate leadership is in the loop in order to move quickly on new regulatory advantages. In general, the regulatory affairs director will communicate within a broad area of a firm, and beyond, with regulators and others outside the company.

The practical aspects 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 much travel one of these professionals might do, and what his or her expense account might look like. A regulatory affairs leader or director for a larger or multi-national firm might have a lot more regulatory learning to do in order to understand how agencies work in foreign nations or regions, for example, in Asia, the Middle East, or the European Union.

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