Vice President of Regulatory Affairs (AI/ML)

Location: South San Francisco, California, United States. Work onsite three days per week or hybrid at approximately one week per month, with additional travel for conferences and health authority engagements.

Salary: $313,000–$333,000 annual starting salary for successful US-based applicants, plus eligibility for an annual performance bonus and equity incentive plan.

Company

hirify.global is a physical AI drug discovery and development company using machine learning and multimodal biological data to develop therapeutics, diagnostics, and patient biomarkers.

What you will do

• Build and lead the regulatory affairs function across neurology/neurodegeneration, metabolism/cardiovascular, and ophthalmology.
• Develop global regulatory strategies for small molecules, biologics, oligonucleotides, diagnostics, laboratory biomarkers, and digital biomarkers.
• Lead regulatory strategy for clinical-stage assets from IND/CTA through clinical proof-of-concept and later NDA, BLA, and MAA submissions.
• Direct the preparation, review, assembly, and submission of regulatory dossiers across clinical, CMC, device, and nonclinical functions.
• Serve as the primary interface with the FDA and EMA and oversee engagement with other health authorities and ethics committees.
• Shape emerging AI/ML regulatory policy through publications, presentations, stakeholder engagement, and executive communication.

Requirements

• 10+ years of regulatory affairs experience in biotechnology and/or pharmaceuticals, including direct regulatory leadership and management experience.
• Experience taking therapeutics and diagnostic biomarkers from first-in-human development through proof-of-concept to NDA/BLA submission.
• Experience in metabolic disease, neurology/neurodegeneration, or oncology.
• Advanced degree in life sciences, technology, chemistry, or a related discipline, with regulatory science education or equivalent practical experience.
• Deep knowledge of drug, diagnostic, and device regulations, good clinical practice, clinical trial design, clinical pharmacology, biostatistics, and clinical operations.
• Ability to collaborate across clinical, translational, computational, and life sciences teams and build a new function from the ground up.

Nice to have

• Experience with regulatory approvals involving computationally enabled tools or biomarkers, particularly AI methods.

Culture & Benefits

• Annual performance bonus plan and equity incentive plan.
• 401(k) plan with employer matching.
• Medical, dental, vision, mental health, and well-being coverage.
• Open flexible vacation policy and paid parental leave.
• Quarterly learning budget, home office setup stipend, and monthly cell phone and internet stipend.
• Onsite meals, barista access, and commuter bus service from across the Bay Area.