Careers in Regulatory Affairs

Career opportunities for those trained in chemistry and biology extend beyond academia and medicine to interdisciplinary roles such as pharmaceutical regulatory affairs (RA). RA operates at the interface of science, law, and business, applying scientific rationale along with statutory regulations and business demands to enable regulatory approval throughout drug development. RA is responsible for all interactions with health authorities from initial clinical trials through marketing applications and beyond. An RA professional influences and collaborates with diverse groups from R&D scientists to project teams to global regulators. Strong communication skills are essential to successfully providing appropriate clinical, nonclinical, and CMC (chemistry, manufacture, and controls) information to regulatory bodies. Creativity is required in the development and negotiation of regulatory strategy with both internal teams and regulators worldwide. Preparation for a career in RA can include bench top research experience, project development team membership, and formal education. The dynamic nature of drug development provides ample opportunity for continued learning and growth throughout a career in RA.