Senior Vice President of Regulatory Sciences (Biotech)

Location: Boston, Massachusetts, United States

Salary: $365,000–$410,000 annually, plus bonus and equity incentives.

Company

hirify.global is a clinical-stage biotechnology company developing programmable mRNA therapeutics for oncology and autoimmune disease using its Signal Stack platform.

What you will do

• Build and lead the Regulatory Sciences function across global strategy, CMC, operations, and vendor management.
• Own regulatory strategy for clinical and preclinical programs and align regulatory plans with the company’s scientific platform.
• Lead interactions with FDA CBER, TGA, EMA, and other global health authorities.
• Partner with R&D, Clinical, and Technical Operations to ensure data packages and study designs are regulatory-ready.
• Advance regulatory strategies for accelerated development paths, novel mechanisms, and next-generation therapeutic modalities.
• Advise senior leadership on portfolio prioritization, risk management, and long-range development planning.

Requirements

• Bachelor’s degree in a scientific discipline; a Master’s, PharmD, or PhD is strongly preferred.
• 20+ years of regulatory strategy experience in biotechnology or pharmaceuticals, including building or scaling regulatory functions.
• Successful experience with INDs, BLAs, and global submissions.
• Deep oncology experience and hands-on experience engaging FDA/CBER and other global health authorities.
• Strong understanding of global regulatory frameworks and experience applying them to platform-based assets.
• Strong communication and leadership skills, with the ability to operate effectively in a fast-moving startup environment.

Nice to have

• Experience with RMAT, Breakthrough Therapy, or Orphan Drug Designation.
• Experience in gene and cell therapies or rare disease.

Culture & Benefits

• Fast-paced, entrepreneurial, team-focused small-company environment.
• Health, dental, and life insurance.
• Open paid time off and work/life flexibility.
• Onsite lunch catering and commuter support.
• Professional development support and collaboration with the founding executive team and scientific advisors.