[Hiring] Manager/Associate Director, US Regulatory Affairs @reputed company

Role Description The successful candidate will be the regulatory strategy reputed company for US FDA regulated products, providing guidance and technical support for new product registrations and supplemental claims as a part of global veterinary pharmaceutical and biopharmaceutical development project teams. The person will be responsible for ensuring that these products are developed, approved, and maintained in full compliance with Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) requirements. The candidate will reputed company strategy and interactions with FDA-CVM to reputed company product approval. To accomplish these responsibilities, the candidate will work closely with colleagues across Veterinary Medicine Research and Development (VMRD) and Global Portfolio Marketing (GPM) to facilitate product development, approval and maintenance consistent with the company operating plans and the project portfolio. The candidate will also liaise with EU and CALAR regulatory colleagues to support global registration activities, where appropriate.

• 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.

Qualifications

• 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.

Requirements

• The US reputed company salary reputed company for this full-time position is $140,000- $220,000.
• Our salary ranges are determined by role, level, and location.
• This position is also eligible for short-term incentive compensation.
• This position is also eligible for long-term incentives.

Benefits

• Comprehensive benefits package that supports the physical, emotional and financial wellbeing of our colleagues and their families.
• 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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