• Serve as regulatory subject matter expert and member on multidisciplinary project teams (food and companion animal) responsible for developing veterinary pharmaceutical and biopharmaceutical products • Develop and implement the regulatory strategy for assigned teams, accepting the responsibility of all US FDA regulatory submissions and interactions for that project • Serve as liaison with Global Research and other VMRD colleagues to help provide early regulatory input into early phase projects • Liaise with GPM and Therapeutic Area Leads to establish suitable product profiles, regulatory jurisdiction, label claims, product support materials, as well as project progression documentation • Assemble original and supplemental applications and coordinate subsequent responses to US Regulatory Authority questions • Liaise directly with FDA-CVM as needed to achieve objectives • Liaise with EU and CALAR regulatory staff to facilitate global registration activities, where appropriate