The director of regulatory affairs handles various regulatory matters in the public and private sectors.
A director of regulatory affairs is a professional involved in the management of regulatory affairs. While governments are often responsible for carrying out regulatory work, directors of regulatory affairs are not always located within government. Across a wide range of companies across many different industries, Regulatory Affairs Directors will be in positions that effectively manage all of the company’s regulatory responsibilities and proactively anticipate regulatory challenges in the countries in which the company operates.
A director of regulatory affairs working for a US company may, for example, be the “designated person” to communicate with the US Food and Drug Administration. This regulatory agency is the main regulator of many goods of consumption. The director of regulatory affairs can read and respond to letters from the FDA, including “warning letters” about unapproved activities or products. The FDA can also contribute to product development by providing feedback on planned future products.
Many companies expect their director of regulatory affairs to develop an overall regulatory strategy that anticipates and prevents problems related to non-compliance with any type of environmental or consumer law. The director of regulatory affairs may be responsible for obtaining the necessary licenses for all projects and products. This professional is likely to spend a lot of time reading documents, as many of a given company’s regulatory requirements are based on testing and “as directed” submissions, where the language of a submission can determine the results.
Teams working on regulatory-related investigations 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 have been marked for some other reason. These project teams can report to the AR director as a way to ensure the right 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 the company and beyond, with regulators and others outside the company.
The practical aspects of the job of a director of regulatory affairs have a lot to do with the scope and size of the company. Observing the company’s operations will tell outsiders a lot about how many trips one of these professionals can take and what their expense account would look like. A leader or director of regulatory affairs for a larger or multinational company may have much more regulatory training to understand how agencies work in foreign countries or regions, for example in Asia, the Middle East, or the European Union.