Manager/Associate Director – US Regulatory Affairs
Posted 2026-05-05
Remote, USA
Full-time
Immediate Start
- Job Description:
- 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
- Requirements:
- 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
- Benefits:
- healthcare and insurance benefits beginning on day one
- a 401K plan with a match and profit-sharing contribution from Zoetis
- 4 weeks of vacation