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
Provide regulatory support and guidance regarding Global Manufacturing initiatives and Commercial market enhancements
Serve on industry working groups to engage with FDA-CVM on current and proposed policy and regulation

Master’s or DVM and/or PhD degree, in a relevant scientific discipline (animal science, veterinary medicine, immunology, toxicology/pharmacology or similar)
8+ years’ experience between US regulatory affairs and a related animal health discipline, involving interaction with the FDA-CVM
Demonstrated abilities in areas of regulatory interpretation and procedures including phased, original, and supplemental applications
Understanding of the veterinary medicinal product development process, including early and late-stage development activities
Knowledge of safety/efficacy and dossier assembly for FDA-CVM
Knowledge in the production and testing of biopharmaceutical veterinary medicinal products is desirable
Excellent oral and written communication and negotiation skills and a demonstrated ability to multi-task and work in a global team environment (including virtual)
Fluency in English required
Excellent functional knowledge of Microsoft platforms and associated Office suite programs
Well-developed verbal and written communications skills and organizational strategies

Manager/Associate Director – US Regulatory Affairs

Key skills