• Independently serve as the regulatory representative on cross-functional teams. • Communicate regulatory strategies and risk assessments to cross-functional teams and senior leadership, as needed. • Collaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program Management, and external consultants to align regulatory results and ensure strategic integration of regulatory considerations into program plans. • Independently lead the central messaging, preparation, and submission of high-quality, regulatory-complaint regulatory dossiers. • Proactively communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teams. • Provide regulatory review of documentation prepared by other technical functions supporting product development activities (e.g., clinical protocols, clinical study reports, statistical analysis plans, etc.) in accordance with regulatory guidelines/requirements. • Provide leadership and management for the coordination and preparation of submissions consistent with regulatory requirements and in accordance with corporate strategy and timelines. • Ensure accuracy and consistency of regulatory submissions and correspondence. Handle vendor/consultant roles, where applicable. • Serve as the regulatory point of contact for interactions with FDA and other global health authorities. • Critically review nonclinical and clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance. Provide regulatory strategic guidance on documents and submission plans to align with study and company objectives. • Interact directly with regulatory agencies; manage agency interactions. • Ensure submissions to regulatory health authorities are complete, organized, of high quality, and compliant with applicable regional regulations. • May assist with due diligence to support business development opportunities. • Provide leadership within the Regulatory department, identifying and managing through completion departmental and cross-project initiatives and regulatory obligations.