Regulatory Affairs

Regulatory affairs are the processes and activities related to the regulation of drugs, medical devices, diagnostics, biologics, and therapeutic products, such as cosmetics, food additives and other consumer products. Regulatory affairs specialists ensure that products meet, or exceed, requirements set by regulatory authorities to ensure safety, efficacy, and quality of these products. They are responsible for obtaining, interpreting and applying appropriate laws, regulations, and standards in order to ensure compliance with government regulations and international standards. Regulatory affairs help ensure that products are safe and effective for the public. Additionally, regulatory affairs can provide assurance that products meet requirements for import and export and facilitate market access in foreign countries. This can help to increase consumer confidence, ensure product quality, and reduce the risk of regulatory actions.