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

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
Excellent functional knowledge of Microsoft platforms and associated Office suite programs
Fluency in English required

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory strategyUS FDA regulatory submissionsregulatory interpretationdossier assemblysafety/efficacy knowledgeveterinary medicinal product developmentphased applicationsoriginal applicationssupplemental applicationsglobal registration activities

Soft Skills

communicationcollaborationliaisonproject managementinterpersonal skillsorganizational skillsproblem-solvingleadership

Certifications

Master’s degreeDVMPhD