Lead and operationalize PRAM support for US product launches and critical milestones, including PDUFA approval, Day 0 readiness, OPDP interactions, Form 2253 submissions, and end-to-end lifecycle activities (e.g., material approval, archival, and label change processes) to ensure timely, compliant execution. Maintain business system ownership of the P&E and USRC workflow and content management system, while driving continuous optimization through adoption of advanced capabilities (e.g., Tier Review, pre-checker, and emerging tools), partnering with stakeholders to solve operational challenges, and ensuring adherence to SOPs, record retention policies, and compliant day-to-day execution.