Manager Sponsor Regulatory Affairs & Institutional Trial Compliance

Responsibilities: Provides strategic and operational leadership for the Office of Regulatory Affairs and Research Oversight in the Division of Institutional Research, responsible for sponsor regulatory oversight of institutionally sponsored clinical trials conducted throughout the health system. Ensures full compliance with FDA regulations, ICH Good Clinical Practice, federal requirements, state requirements, and institutional policies governing sponsor responsibilities. Leads regulatory infrastructure that supports trial startup, conduct, safety oversight, multi-site expansion, reporting obligations, quality systems, and inspection readiness. Partners across the enterprise to create an efficient, scalable, and high performing sponsored trials program.

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. Safety Oversight, Quality Systems, and Inspection Readiness: Establish sponsor systems for adverse event review, serious adverse event reporting, unanticipated problem management, and safety signal escalation Coordinate oversight bodies such as DSMBs, independent medical monitors, adjudication committees, and safety review committees when required Maintain sponsor Trial Master File standards, completeness, version control, and inspection readiness Ensure regulatory data fields are complete in electronic research support system Partner with Data Manager to conduct IND/IDE tracking and create reporting dashboards Partner with Quality Assurance, Compliance, IRB, and operational leaders on audits, monitoring findings, CAPAs, and corrective actions Lead internal audit readiness program and conduct mock FDA inspections Lead preparation for FDA inspections, sponsor audits, and external regulatory reviews Identify systemic compliance risks and implement preventive controls Governance, Policy, Training, and Enterprise Collaboration: Develop and maintain sponsor SOPs, work instructions, templates, governance charters, and operational standards Create standardized pathways for investigator initiated and institutionally sponsored trials Educate investigators, research staff, executives, and operational departments on sponsor obligations and regulatory expectations Partner with IRB, legal, contracting, finance, pharmacy, laboratory, privacy, data governance, and revenue cycle teams to align study operations Advise investigators on regulatory and institutional compliance documentation needs during protocol development to improve feasibility and regulatory success Promote a culture of accountability, service, compliance, and operational excellence across the research enterprise Leadership, Talent Management, and Financial Stewardship: Build, lead, mentor, and evaluate a high performing sponsor regulatory affairs team Establish staffing models aligned with institutional trial volume and complexity Work with project coordinators to set performance metrics for study startup timelines, as it pertains to regulatory and compliance documentation Develop and manage departmental operating and capital budgets Identify efficiencies, automation opportunities, and scalable systems that improve productivity and reduce cycle times Provide regular dashboards and strategic updates to executive leadership Support long term growth of the institutional sponsored trial portfolio EducationBachelors Required Masters in health administration, public health, regulatory science, business, nursing, pharmacy, law, or related field Preferred Experience 6 years, of progressive clinical research experience Required 3 years, of leadership experience in regulatory affairs, sponsor operations, quality systems, or clinical trial administration Required 3 years, of experience with IND, IDE, FDA submissions, or sponsor held trials Preferred 3 years, of experience building teams, systems, and operational infrastructure Preferred License and Certifications Society of Clinical Research Associates CCRP Preferred Association of Clinical Research Professionals CCRC Preferred Regulatory Affairs Professionals Society RAC PreferredPMP Preferred