Regulatory Affairs

Regulatory Affairs refers to the branch of industry that ensures that companies comply with all of the regulations and laws pertaining to their business processes, particularly in areas such as pharmaceuticals, biotechnology, medical devices, and food safety. Professionals in regulatory affairs work to obtain and maintain approval for products from regulatory bodies, like the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe. This involves preparing and submitting documents, managing correspondence with regulatory agencies, and ensuring that products meet the necessary legal standards for safety, efficacy, and quality. Regulatory affairs also involve monitoring changes in legislation and guidelines and advising the organization on compliance issues. The ultimate goal is to facilitate product development and market access while ensuring that the public remains protected from potential risks associated with new products.