Regulatory Affairs Specialist

We’re looking for a highly organized and detail-driven Regulatory Affairs Specialist to join our growing clinical research team in Miami. This role is ideal for someone experienced in managing regulatory submissions, maintaining inspection-ready study files, and supporting fast-paced clinical trial operations across multiple sites.What You’ll DoManage IRB submissions, amendments, and regulatory documentationMaintain accurate and audit-ready regulatory files (TMF/eTMF)Ensure compliance with FDA, ICH-GCP, and sponsor requirementsSupport study startup, activation, and ongoing trial maintenanceCollaborate with sponsors, investigators, CROs, and clinical staffWhat We’re Looking For2+ years of regulatory experience in clinical research, SMO, or CRO settingsStrong knowledge of FDA and ICH-GCP guidelinesExcellent organization and communication skillsExperience with IRB submissions and multi-study managementBilingual English/Spanish is a plusJoin a fast-growing research organization committed to advancing innovative clinical trials and improving patient outcomes.