• Provides regulatory guidance throughout the clinical development life cycle • Compile, coordinate and review applications to Regulatory Authorities • Develops and/or reviews documents intended for submission to the Regulatory Authorities • Serve as representative of Global Regulatory Affairs at project team meetings • Works within a project team, and where necessary, leads project for the region or globally • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets • Maintenance of project plans, project trackers and regulatory intelligence tools • Assist in development of Regulatory Affairs Specialists and other operational area staff • Provide input into regulatory strategy and timeline development for new study opportunities • Participates in maintaining and executing on the corporate quality initiatives