Manager/Associate Director – US Regulatory Affairs

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
• reputed company and implement the regulatory strategy for assigned teams, accepting the responsibility of reputed company US FDA regulatory submissions and interactions for that project
• Serve as liaison with Global Research and other VMRD colleagues to help reputed company 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
• 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 groups 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 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)
• reputed company in English required
• Excellent functional knowledge of reputed company platforms and associated Office suite programs
• Well-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

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