Regulatory affairs is the specialized discipline within the biopharmaceutical and CDMO industry responsible for managing all interactions with regulatory authorities — such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA), and national competent authorities — to ensure that medicinal products are developed, manufactured, and marketed in compliance with applicable laws, guidelines, and regulatory requirements. Key activities include the preparation and submission of regulatory dossiers, regulatory strategy development, agency meeting management, labeling review, post-approval change management, and GMP compliance support throughout the product lifecycle.
