Our client is seeking a senior-level regulatory affairs executive to lead the registration of the early-stage prescription product portfolios in the companion and equine animal sectors. The company is committed to identifying animal health market opportunities where it can develop species-specific products that leverage its broad intellectual property portfolio and deep pipeline. The successful candidate will drive all US and OUS regulatory initiatives, providing regulatory expertise, a strong network of industry contacts and a successful track record of approval of new and innovative products for companion animals and/or production animals. Candidates must be skillful strategists and critical thinkers who are excited about the opportunity to serve in a C-level capacity at this innovative animal health company. This position could be a virtual role.
The incumbent will be responsible for direct submission activities for a variety of veterinary pharmaceuticals, will compile and submit registration dossiers to FDA CVM in a timely manner, will direct and manage interface/written communications on regulatory and technical matters with FDA CVM as well as regulator responses to submission. The incumbent will prepare and coordinate CMC areas of submissions to CVM, reviewing manufacturing documentation and reports. The incumbent will maintain current knowledge of applicable regulatory requirements and guidelines, manage the label approval process for regulatory affairs with minimal supervision and will assure that product label claims are in compliance with all relevant laws and regulations.
Qualifications include 4+ years of experience in veterinary pharmaceutical regulatory role with demonstrated success in achieving regulatory approvals for veterinary pharmaceuticals. Experience should preferably include writing submission to FDA CVM and obtaining NADAs. A scientific degree in an appropriate biomedical subject (life sciences, biology, pharmacy, veterinary medicine, engineering). Experience working both independently and in multidisciplinary, geographically dispersed teams, ability to prepare and present information to regulatory agencies and other scientific groups, experience submitting documents to CVC electronically, knowledge of European registration process is a plus. The successful candidate will have a solid understanding of the manufacturing and testing of veterinary pharmaceuticals and be skilled using the new electronic submission process of CVM. Other qualifications include solid organizational skills, detail-oriented and able to maintain accuracy in a fast-paced environment. It is important to be adept with MS Office suite, Adobe and other software and have excellent medical/technical writing and communication skills.
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