Manager Sponsor Regulatory Affairs & Institutional Trial Compliance

ESSENTIAL FUNCTIONS Sponsor Regulatory Strategy and Agency Compliance: Lead implementation of regulatory strategy for institutionally sponsored clinical trials, including drug, device, biologic, behavioral, and observational studies Determine regulatory pathway for each study, including IND, IDE, exempt, abbreviated, or non-FDA regulated status Oversee preparation and submission of INDs, IDEs, amendments, annual reports, safety reports, protocol changes, and closeout filings as required Serve as primary institutional contact with FDA and other regulatory agencies regarding sponsor matters Monitor changes in regulations, guidance, and enforcement trends, then implement required operational changes Ensure fulfillment of sponsor commitments, reporting deadlines, and regulatory obligations Provides guidance to leadership on regulatory risk, escalation items, and remediation strategy. Trial Startup, Lifecycle Management, and Sponsor Oversight: Lead sponsor regulatory and compliance startup processes from concept approval through study activation Oversee regulatory readiness for protocol finalization, informed consent documents, investigator qualifications, site documents, and essential regulatory records Approve activation of internal and external participating sites once sponsor requirements are met Direct amendment implementation processes across all participating sites Oversee study closeout, final reporting, archival readiness, and record retention requirements Support expansion of institutional trials into multi-site networks and affiliated partners Ensure delegation of sponsor responsibilities to CROs, monitors, vendors, or external partners is documented and controlled Ensure trial institutional reporting requirements such as to CT.Gov, registration and reporting are completed within the institutional regulatory guidelines.