• Provides regulatory guidance throughout the clinical development life cycle • Compile, coordinate and review applications to Regulatory Authorities • Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees • Serve as representative of Global Regulatory Affairs at project team meetings • Works within a project team, and where necessary, leads project for the region or globally • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets • Maintenance of project plans, project trackers and regulatory intelligence tools • Assist in development of Regulatory Affairs Specialists and other operational area staff • Provide input into regulatory strategy and timeline development for new study opportunities • Participates in maintaining and executing on the corporate quality initiatives across business units

• Lead regulatory activities and submissions independently, with prior experience in areas such as CTA/IND/MAA EU CTR and UK-specific submissions essential experience here required • Management of activities associated with obtaining initial, amendment and other central authority approvals • Companion diagnostics, IVDR submissions, clinical performance studies experience would be beneficial • Oversee preparation of core regulatory packs. • Provide broad regulatory support across EU and UK requirements. • Provide regulatory guidance and efforts to internal teams • Participate in agency interactions and regulatory submissions • Contribute to developing best practices within ICON Regulatory Affairs through your insight of regulatory processes and guidelines • Work collaboratively as part of a regulatory or cross-functional team, depending on project size and nature

• Track caregiver attendance, clock-ins/outs, and full shift completion in real time using Authenticare, quickly contact caregivers for missed, late, or early shifts, guide them on correcting or making up time, record reasons for delays or missed visits, maintain accurate schedules, and run/review reports to track attendance, ensure compliance, and prevent lost revenue • Maintain and adjust schedules in ERSP to reflect actual hours worked and ensure correct payroll and billing • Coordinate with team members across five regions to balance shifts and ensure full coverage • Support caregiver retention through accurate scheduling, accountability, and follow-through • Communicate professionally with caregivers via phone and VoIP, balancing support with firm expectations • Assist management in improving EVV (Electronic Visit Verification) processes and overall scheduling efficiency

• Ensure the effectiveness of the organization’s Medicare compliance program across Medicare Advantage (MA) and Part D lines of business. • Provide oversight of Third-Party Marketing Organizations (TPMOs) and First-Tier, Downstream, and Related Entities (FDRs). • Drive compliance risk management, monitoring, remediation, and continuous improvement. • Assist with annual and ongoing Medicare compliance risk assessments. • Develop and deliver targeted training for sales, marketing, operations, customer service, enrollment, and pharmacy teams; track completion and measure effectiveness. • Prepare clear, accurate compliance dashboards and reports for leadership, Compliance Committee, and Board-level governance.