Vice President, Regulatory Affairs

Location: Remote - US

Salary: $280,000–$340,000 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

• Own the company-wide regulatory strategy across CMC and clinical programs from early development through approval and post-approval lifecycle management.
• Lead CMC regulatory activities, including filing strategy, CMC authoring and review, manufacturing partner oversight, inspections, and post-approval change management.
• Lead clinical regulatory activities, including IND strategy, protocol review, pivotal study alignment, and integration of clinical data into submissions.
• Direct submission strategy and execution, including pre-submission meetings, formal filings, agency communications, labeling, and regulatory intelligence.
• Manage post-approval obligations, including periodic reports, labeling updates, study commitments, and CMC variation filings.
• Build the regulatory organization, governance frameworks, information management infrastructure, eCTD publishing capability, and submission archiving standards.

Requirements

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related scientific discipline, or equivalent biotechnology expertise.
• 18+ years of regulatory affairs experience, including 10+ years in senior regulatory leadership roles within sponsor organizations.
• Deep CMC regulatory expertise in small-molecule drug development, OSD formulation, manufacturing strategy, CMC authoring, and post-approval change management.
• Experience leading regulatory teams across both CMC and clinical functions and bringing at least one product through NDA, MAA, or equivalent approval.
• Proven experience with agency interactions, post-approval activities, ICH guidelines, and global regulatory requirements.
• Executive presence and ability to serve as the primary regulatory authority and agency liaison.

Nice to have

• Human health pharmaceutical or biotech experience; animal health experience is a plus.
• Experience with FDA CVM regulations and veterinary drug pathways such as NADA or ANADA.
• Experience with EMA, PMDA, NMPA, eCTD standards, commercial launches, and post-approval infrastructure.
• Experience scaling organizations through growth, transformation, or regulatory milestone events.

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.
• Three-day weekends are extended to four-day weekends.
• Company equity options and paw-ternity leave for dog adoption.
• Culture focused on methodological risk reduction, cross-functional collaboration, transparency, expertise without ego, and respect for all life.