• Develop regulatory strategies for clinical development programs (which may range from FIH through post-marketing stage). • Provide solid regulatory solutions and guidance to the cross-functional teams and senior management. • Provide tactical support and operational expertise with “hands on” support as needed. • Assess project plans and timelines. • Work collaboratively to ensure all projects are appropriately prioritized and key goals are met on time. • Ensure compliance of regulatory strategies and submissions. • Oversee preparation and review of regulatory submissions and responses. • Monitor regulatory trends and ensure proactive strategy adjustments. • Other duties and responsibilities as assigned.