Regulatory Specialist

Regulatory Specialist coordinating and maintaining regulatory documentation for clinical trials, assisting in submissions to IRBs and sponsors, and ensuring compliance with ICH-GCP, FDA regulations, and sponsor-specific requirements. Maintains regulatory files (ISFs and binders) and electronic systems (e.g., CRIO, Veeva, Complion) to stay current and audit-ready; supports study start-up activities, tracking of approvals and licenses, and liaison activities between research staff, investigators, sponsors, and IRBs. Participates in audits, monitoring visits, and sponsor inspections, tracks submission timelines, and contributes to regulatory meetings by taking minutes and updating document status.