Be the regulatory strategy lead for US FDA regulated products
Provide guidance and technical support for new product registrations and supplemental claims
Ensure that these products are developed, approved, and maintained in full compliance with FDA-CVM requirements
Lead strategy and interactions with FDA-CVM to enable product approval
Work closely with colleagues across VMRD and GPM to facilitate product development
Liaise with EU and CALAR regulatory colleagues to support global registration activities
Serve as regulatory subject matter expert and member on multidisciplinary project teams
Develop and implement the regulatory strategy for assigned teams
Assemble original and supplemental applications and coordinate responses to US Regulatory Authority questions
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

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.

Manager/Associate Director, US Regulatory Affairs

Key skills