The Regulatory Affairs Specialists I is an entry-level position responsible for preparing initial FDA submission as well as subsequent filing including but not limited to modified protocols, consent forms, serious adverse events (SAEs), and annual progress reports (APRs). The Regulatory Affairs Specialists I works under immediate supervision of the Regulatory Affairs Unit Manager. Because this is an entry level position, it will be expected that the Regulatory Affairs Specialist I will learn and apply relevant parts of the Code of Federal Regulations (e.g. 21 CFR 312, 21 CFR 812, etc.).
UAMS offers amazing benefits and perks: