A regulatory affairs director is a professional who works in the regulatory field. Regulatory affairs directors are not always found in government, despite the fact that governments are typically responsible for regulatory work. Regulatory affairs directors will work for a variety of companies in a variety of industries, managing all of the firm’s regulatory responsibilities and anticipating regulatory challenges in the countries where the company operates.
For example, a regulatory affairs director working for an American company might be the “point person” for communicating with the US Food and Drug Administration. This agency is in charge of regulating a wide range of consumer goods. The regulatory affairs director may be responsible for reading and responding to FDA letters, such as any “warning letters” about unapproved activities or products. The FDA can also help with product development by providing feedback on upcoming products.
Many companies expect their regulatory affairs director to develop a comprehensive regulatory strategy that anticipates and avoids issues arising from non-compliance with any environmental or consumer law. The director of regulatory affairs may be in charge of obtaining all necessary licenses for all projects and products. Because much of a firm’s regulatory requirements rely on evidence and submissions “as stated,” where the language of a submission can determine outcomes, this professional will likely spend a lot of time reading documents.
The regulatory affairs director may also provide advice or oversight to teams working on regulatory research. This could include products that the FDA has not yet approved or that have been flagged for another reason. These project teams may report to the RA director to ensure that the appropriate leadership is kept informed so that new regulatory advantages can be implemented quickly. In general, the regulatory affairs director will communicate with regulators and others outside the company as well as within the firm.
The scope and size of a company will have a big impact on the practical aspects of a regulatory affairs director’s job. Outsiders can learn a lot about how much travel one of these professionals does and what his or her expense account looks like by looking at the company’s operations. A regulatory affairs leader or director for a larger or multi-national company may need to learn more about regulatory processes in other countries or regions, such as Asia, the Middle East, or the European Union.