Director, Regulatory Affairs - Clinical (Veterinary Medicine)

Location: Remote - US

Salary: $155,000–$205,000 per year

Company

hirify.global is a clinical-stage veterinary medicine startup developing longevity drugs intended to help dogs live longer, healthier lives and pursuing FDA approval for a new category of veterinary prescription medicines.

What you will do

• Own FDA Center for Veterinary Medicine clinical regulatory strategy from INAD planning through pivotal submissions.
• Author and review INAD filings, study reports, clinical trial materials, agency correspondence, and regulatory records.
• Lead preparation for FDA CVM meetings, including briefing documents, meeting requests, questions, and follow-up memoranda.
• Provide regulatory guidance on active studies, including SAE submissions, BIMO preparedness, NCIE reports, protocols, informed consent forms, and amendments.
• Monitor CVM guidance, policies, and precedents while identifying and resolving regulatory risks across R&D, CMC, clinical, commercial, data management, and legal functions.
• Manage and mentor 1–2 direct reports and serve as the internal subject matter expert on FDA CVM clinical requirements, labeling, and pre-approval communications.

Requirements

• 10+ years of regulatory affairs experience, including 3+ years in animal health.
• Direct experience owning FDA CVM relationships, INADs, regulatory submissions, and FDA CVM in-person meetings.
• Extensive knowledge of FDA CVM clinical development pathways, policies, submission requirements, and regulatory limitations.
• Bachelor’s degree in biology, veterinary medicine, regulatory affairs, or a related field; relevant experience may substitute for a specific degree.
• Strong analytical, writing, communication, judgment, and cross-functional collaboration skills.
• Ability to operate as a senior individual contributor while mentoring junior team members and working autonomously in a fast-paced startup environment.

Nice to have

• Experience across multiple drug types, including small molecules, biologics, and injectables.

Culture & Benefits

• Full-coverage medical, dental, and vision insurance for employees and dependents.
• $1,000 home office equipment stipend and a $1,200 annual learning budget.
• $250 monthly wellness budget, unlimited vacation, and paid holidays.
• Four-day weekends when a three-day weekend occurs, plus paw-ternity leave for adopting a dog.
• Company equity options grant for new hires.
• High-autonomy, cross-functional culture focused on rigorous experimentation, transparency, humility, and respect for all life.