GLOSSARY: Pharmaceutical Regulatory Affairs

Pharmaceutical Regulatory Affairs, or Pharma Regulatory Affairs, refers to the professionals who maintain regulations from within the industry. The pharmaceutical industry is the most regulated of all industries. Regulatory affairs professionals are key, but perhaps overlooked, players in drug development. They are the primary communications link between the company and agencies such as FDA, and they are responsible for keeping up with the increasing scope and complexity of regulations. In the pharmaceutical industry, regulatory affairs professionals have expertise in the legal and regulatory environments, as well as in clinical research protocols.