Director of Regulatory Affairs
Company Summary:
My client, a pharmaceutical manufacturing company focusing on animal health is looking to add a Regulatory Affairs Director to their team! This role will be based in Pensacola, Florida.
The Regulatory Affairs Director will be responsible for:
- Designing and executing non-clinical and clinical study protocols in compliance with FDA CVM regulations
- Leading discussion and negotiating product development plans with the FDA
- Protocol and therapeutic area training of project teams for conducting non-clinical and clinical studies
- Monitoring non-clinical and clinical projects and studies, including the consultants, study site investigators, clinical research organizations, and academic research organizations
- Authorizing and assembly of applicable regulatory submissions
The Regulatory Affairs Director should have the following qualifications:
- DVM or PhD in animal life sciences
- 10+ years combined non-clinical and clinical study development experience related to animal drug development and experience with FDA CVM drug approval process
- Affiliation with animal health related professional associations
- Experience leading high functioning teams
