Study Start Up and Regulatory Affairs Specialist

The Specialist, Study Start Up and Regulatory Affairs leads and coordinates all activities related to achieving site initiation readiness for clinical trials. This role ensures regulatory compliance, serves as a key liaison between internal teams, clients, and external stakeholders, and manages the delivery of study start-up and regulatory milestones. The position involves preparing and reviewing essential documentation, negotiating clinical site agreements, and developing regulatory strategies to support complex trials in rare disease and oncology.