RegulatoryStrategyDirector

**Job Description** **General Summary:** The Regulatory Strategy Director will be responsible for the development and implementation of innovative global/regional regulatory strategies for assigned projects within the Vertex portfolio. This position will play a major role in shaping cohesive regulatory strategy for assigned program(s) and ensuring effective integration of broad regulatory ideas/tactics supporting program strategy. This roles assignments may be global, regional or local depending on the position and assigned region. This role will understand and translate regulatory, scientific, operational and business knowledge into effective implementation plans and strategy. **Key Duties and Responsibilities:** * Leads the development of regulatory strategy for assigned projects/regions in development (from first-in-human to post marketing application stage) outlined in Global Regulatory Strategy Documents * Represents GRA on core development functional teams, project teams, and collaborate with regional leaders and teams to ensure unified regulatory input into clinical programs and commercial strategy * Addresses complex issues, providing innovative regulatory solutions and guidance to cross-functional teams and align communication to and from cross-functional teams, GRA functional team and GRA leadership * Anticipates global regulatory changes and develops proactive strategy accordingly * Shapes the regulatory strategy for regulatory submission documents and Health Authority communications * Counsels and advises GRA leadership on status of global Regulatory Affairs strategies and tactics, procedures and practices * Ensures the global regulatory strategy for a given project is consistent with the business objectives and is compliant with current regulations and guidance * Manages project plans and timelines to ensure all projects are appropriately prioritized and key goals are met on time * Contributes to the continuous improvement of existing department process