• Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports. • Assess change controls and provide regulatory assessments of quality changes in production and quality control. • Review study reports from the quality control and production departments to ensure compliance with regulatory requirements. • Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies. • Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities. • Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions. • Identify, escalate, and mitigate risks associated with regulatory procedures and activities.

• Lead the execution of the enterprise information security GRC program and report directly to the CISO. • Translate the CISO’s cybersecurity strategy and risk tolerance into scalable and defined processes, measurable outcomes, and defensible compliance posture. • Own the security risk lifecycle, including assessments, tracking, remediation, and escalation of material risks to the CISO. • Maintain the security policy framework and translate standards (e.g., NIST CSF, ISO 27001, SOC 2) into actionable control requirements. • Manage security related compliance activities and audits; maintain evidence and track remediation to closure. • Operate the vendor security risk management program and escalate high risk vendors and systemic issues. • Produce concise risk and compliance metrics and dashboards for the CISO and senior leadership. • Mentor GRC staff and act as a trusted advisor to Security, IT, Legal, Privacy, and business teams. • Partner with the CISO and Sr. Manager of Security Operations to update the Strategic Information Security Program.

• Conduct investigations of customer activity to determine whether such activity warrants reporting in accordance with relevant AML regulation and guidance. • Draft and prepare Suspicious Activity Reports (SARs). • Perform blockchain analysis utilizing blockchain analytics to review customer activity, including direct and indirect exposure. • Analyze customer data including, but not limited to, IP addresses, device information and signals, open source intelligence (OSINT), transaction histories, customer identification and source of wealth documentation. • Conduct customer outreach to gather additional information regarding customer activity. • Balance numerous projects, queues and priorities in a fast-paced environment.

• Build and maintain curated datasets and data models (e.g., case, alert, entity, transaction, and risk features) that power compliance controls across Transaction Monitoring, EDD/KYC, and Screening systems. • Own data quality for compliance datasets by implementing validation checks, monitoring, lineage tracking, and documentation to ensure outputs are accurate, complete, and audit-ready. • Partner with cross-functional engineering teams and Compliance stakeholders to close upstream data gaps, standardize instrumentation, and translate control requirements into scalable data structures and feature sets. • Drive detection signal quality improvements by analyzing detection outputs, identifying opportunities to reduce non-actionable noise while protecting sensitivity, and defining success metrics for controlled rollouts. • Execute measurement frameworks for compliance control effectiveness, including coverage, timeliness, stability, and outcome-based metrics, and build repeatable reporting pipelines consumable by Compliance leaders, operations teams, and auditors.