A Regulatory Affairs Specialist is a professional responsible for ensuring that companies comply with all regulations and laws related to their products, particularly in industries like pharmaceuticals, biotechnology, and medical devices. They work closely with government agencies, such as the Food and Drug Administration (FDA), to navigate the approval process for new products and maintain compliance with existing regulations. These specialists prepare and submit necessary documentation, monitor changes in regulations, and provide guidance to their organizations on regulatory requirements. Their role is crucial in helping companies bring safe and effective products to market while minimizing legal risks and ensuring public safety.