Overview of the Regulatory Affairs Certification (RAC) US Exam
The RAC-US certification targets regulatory affairs professionals by validating deep expertise in the lifecycle management of FDA-regulated products including pharmaceuticals, biologics, and medical devices. Candidates must demonstrate proficiency in navigating the Code of Federal Regulations, specifically 21 CFR parts 210, 211, and 820, alongside PDUFA and MDUFA mandates. The examination requires mastery of eCTD submission protocols, pre-market approval pathways, and post-market surveillance frameworks. Furthermore, participants must articulate complex requirements for Good Clinical Practice, Current Good Manufacturing Practice, and Quality System Regulations. Mastery of risk management standards, including ISO 14971, remains essential for analyzing clinical trial data and ensuring institutional compliance within the evolving US regulatory landscape.