Regulatory Affairs Specialist

Regulatory Affairs CoordinatorBachelor's degree required. Three years of experience in a clinical research environment. Direct regulatory affairs experience supporting clinical research, including creating and submitting IRB applications and amendments. Strong organizational skills with the ability to manage multiple deadlines simultaneously. Excellent written and verbal communication skills. Proficiency with Microsoft Office applications and electronic regulatory systems. Ability to work independently and collaboratively in a fast-paced research environment.A clinical research center is seeking a Regulatory Affairs Coordinator to support clinical trials by managing regulatory documentation and ensuring compliance with IRB, FDA, sponsor, and institutional requirements. The ideal candidate will have a bachelor's degree, at least three years of professional experience, and a minimum of one year of direct regulatory affairs experience creating and submitting IRB applications. This role is responsible for preparing IRB submissions, maintaining investigator site files, tracking regulatory approvals, and supporting study start-up through closeout. The coordinator will work closely with investigators, study coordinators, sponsors, and regulatory agencies to ensure timely and accurate submissions. Experience with clinical research regulations, GCP, and regulatory documentation management is required.