Senior Associate Specialist, Regulatory Operations

Location: Remote - US

Salary: $110,000–$160,000 per year

Company

hirify.global is a clinical-stage veterinary medicine startup developing longevity drugs intended to help dogs live longer and healthier lives.

What you will do

• Prepare and review clinical and CMC regulatory submissions and reports.
• Create and package submissions in the CVM eSubmitter tool using author-drafted sections.
• Assemble, format, and publish submissions to FDA CVM and applicable ex-US agencies.
• Manage FDA Electronic Submissions Gateway transmissions, including account administration, receipt reconciliation, and troubleshooting.
• Maintain submission archives, correspondence logs, templates, style guides, and regulatory trackers.
• Collaborate with Research, Clinical Development, CMC, and other teams on labeling and submission documentation.

Requirements

• 3–5 years of regulatory operations experience in human or animal health; animal health experience is preferred.
• Bachelor’s degree in biology, veterinary medicine, regulatory affairs, or a related field; relevant experience may substitute for a specific degree.
• Knowledge of therapeutic submission types, including H-submissions, Z-submissions, IND/INAD, NDA/NADA, biologics, supplements, and meeting requests.
• Hands-on experience drafting, packaging, and submitting communications and regulatory materials to the FDA through the ESG electronic submission system.
• Ability to manage submissions autonomously and collaborate effectively with cross-functional contributors.

Nice to have

• Experience with ex-US regulatory submissions.
• RAPS certification.
• Animal health regulatory experience.

Culture & Benefits

• Full 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, paid holidays, and extended four-day weekends for all three-day weekends.
• Paid paw-ternity leave for adopting a dog and company equity options for new hires.
• Collaborative, cross-disciplinary environment focused on learning by doing and solving novel regulatory challenges.