Director, Regulatory Affairs (February 2016 – Present)Associate Director, Regulatory Affairs Brand and Generic Prescription Products (April 2014 – February 2016)• Regulatory Lead and Health Authority primary contact for approximately thirty (30) applications (IND, NDA, ANDA and PMA)• Manage multiple NDAs simultaneously under initial health authority review• Primary lead for Health Authority communications including telephone and face-to-face meetings• Develop regulatory strategy to support business objectives for product development and life cycle maintenance of ophthalmology, neurology, and pain management therapies• Key contributor to risk mitigation and contingency plans to maintain market continuity• Support project teams and provide regulatory guidance to cross-functional groups• Develop regulatory timelines and track key milestones from development through product market approval/launch• Prepare and author Module 1 documentation for submissions to the US FDA• Develop, review and approve product labeling• Regulatory project management that includes dispatch and tracking activities to support approximately one hundred-twenty (120) applications within group to meet team and compliance timelines• Manage direct reports that support activities to meet organizational objectives• Key contributor in developing, integrating and implementing internal tracking databases and archival repository to maintain regulatory compliance• Develop departmental work instructions/best practices and implement internal processes to support compliance to standard operating procedures