Pegasus Laboratories, Inc. is a full-service Contract Development and Manufacturing Organization, or CDMO, with a very special purpose: improving the lives of animals. Through our leading veterinary brand, PRN Pharmacal, we create trusted veterinary products that promote animal wellness, including behavior modification, urinary incontinence, and seizure management. Our team of professionals, including manufacturing, quality assurance, business development, scientists and chemists, regulatory experts, and veterinarians, offers the complete package, from idea through development and regulatory approval, to production and marketing.

Pegasus Labs, part of the PBI-Gordon Companies, Inc., is 100% employee-owned with more than 500 employee-owners, working together in pursuit of mutual success. We are growing – come join us!

The Director of Regulatory Affairs provides strategic planning, implementation, and management of veterinary non-clinical and clinical studies to support animal health product development. Serve as a scientific and clinical resource to cross-functional teams involved in veterinary product initiatives inclusive of business development opportunities.

• Design and execute assigned non-clinical and clinical study protocols which are scientifically supported and in compliance with FDA CVM regulations.
• Protocol and therapeutic area training of project teams for the conduct of non-clinical and clinical studies, inclusive of vendor management as appropriate.
• Assistance in investigator identification for non-clinical and clinical veterinary studies.
• Monitor non-clinical and clinical studies and projects, inclusive of consultants, study site investigators, academic research organizations, and clinical research organizations.
• Lead scientific discussion and negotiate product development plans with FDA.
• Veterinary medical, scientific, and technical support for project management, data management¸ biostatistics and medical writing.
• Non-clinical and clinical study report writing and or/critical medical review and assessment of written documents.
• Leads in the authorizing and assembly of applicable regulatory submissions (dossiers).
• Manage and lead, direct and indirect, team members.

Qualifications

• DVM or PhD in small animal life sciences
• DVM or PhD in animal life sciences with advanced degree in therapeutic areas of interest to Pegasus pipeline product development for companion animal health preferred.
• Experienced leading high functioning teams.
• Minimum 10 years combined non-clinical and clinical study development experience related to companion animal drug development and experience with FDA CVM drug approval process.
• Minimum 10 years in animal health drug development for FDA approved pharmaceutical veterinary products. Affiliation with animal health related professional associations desired.
• Advanced experience with Microsoft Office Suite
• Knowledgeable with Microsoft D365
• Travel up to 30%