Regulatory Affairs refers to the field of expertise that focuses on ensuring compliance with regulatory requirements in the development, approval, and marketing of pharmaceuticals, medical devices, biologics, and other healthcare products. Regulatory Affairs professionals work closely with regulatory authorities, such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe, to navigate the complex regulatory landscape and ensure that products meet safety, efficacy, and quality standards. They are responsible for preparing and submitting regulatory filings, managing regulatory submissions, monitoring changes in regulations, and ensuring ongoing compliance throughout the product lifecycle.