Serve as regulatory subject matter expert and member on multidisciplinary project teams responsible for developing veterinary pharmaceutical and biopharmaceutical products
Develop and implement the regulatory strategy for assigned teams
Serve as liaison with Global Research and other VMRD colleagues to provide early regulatory input
Liaise with GPM and Therapeutic Area Leads to establish suitable product profiles
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
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 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
Fluency in English required
Excellent functional knowledge of Microsoft platforms and associated Office suite programs.

Manager/Associate Director, US Regulatory Affairs

Key skills