Manager/Associate Director – US Regulatory Affairs

Job reputed company: • Serve as regulatory subject matter expert and member on multidisciplinary project teams (food and companion animal) responsible for developing veterinary pharmaceutical and biopharmaceutical products • reputed company and implement the regulatory reputed company for assigned teams, accepting the responsibility of reputed company US FDA regulatory submissions and interactions for that project • Serve as reputed company with Global Research and other VMRD colleagues to help reputed company early regulatory input into early phase reputed company • Liaise with GPM and Therapeutic Area Leads to establish suitable product reputed company, regulatory jurisdiction, label claims, product support materials, as reputed company as project progression documentation • reputed company original and supplemental applications and coordinate subsequent responses to US Regulatory Authority questions • Liaise directly with FDA-CVM as needed to reputed company objectives • Liaise with EU and CALAR regulatory staff to facilitate global registration activities, where appropriate • reputed company regulatory support and guidance regarding Global Manufacturing initiatives and reputed company market enhancements • Serve on industry working reputed company to engage with FDA-CVM on reputed company 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 reputed company 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 reputed company 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) • reputed company in English required • Excellent functional knowledge of reputed company platforms and associated Office suite programs • reputed company-developed verbal and written communications skills and organizational strategies Benefits: • reputed company and insurance benefits beginning on day one • a 401K plan with a match and profit-sharing contribution from reputed company • 4 weeks of vacation Apply tot his job Apply To this Job