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Senior Vice President of Regulatory Affairs and Clinical Development (remote position based anywhere in the US)

Senior Vice President of Regulatory Affairs and Clinical Development (remote position based anywhere in the US)

Our client is a leading animal health company with a growing portfolio of intellectual property creating therapies for pets worldwide.

In this role, the incumbent will report directly to the CEO and will lead the development and execution of the Clinical Development strategy and business plan and will lead the registration of early-stage prescription product portfolios in the companion animal sector.

In this role the incumbent will be working with the FDA Center for Veterinary Medicine (CVM) to advance the pipeline. The successful candidate will drive all US & foreign 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.

The VP will maintain current knowledge of regulatory requirements and guidelines, will manage the label approval process for regulatory affairs and assure product label claims follow laws and regulations. The VP will lead and collaborate with clinical development staff to plan and execute on all safety and clinical studies. The VP will draft or edit protocols, collaborate with statisticians and KOL’s to implement high quality GCP or GCP studies. The VP will lead adverse event investigations and reporting requirements.

Qualifications:  We are looking for a strategist and critical thinker who is excited to serve at an executive level capacity at an innovative animal health company. The incumbent will be a visionary with high aspirations and will be able to manage multiple complex programs simultaneously in a fast-paced environment.  Doctor of Veterinary Medicine (DVM or equivalent) degree with 4+ years of veterinary pharmaceutical clinical development and regulatory affairs experience with success in achieving regulatory approvals. Strong written and verbal communication skills are required. Our ideal candidate is someone with a growth mindset who is able to thrive in a fast-paced environment. The incumbent may be required to work outside of normal business hours at times to meet critical deadlines.  15% travel may be required.

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