SVP Regulatory Affairs (San Francisco County)

Vice President / Senior Vice President - Regulatory Affairs? U.S. - Remote or Hybrid (Bay Area) | Full-time? Salary Range: $380,000 - $430,000 + Bonus + Equity Lead the regulatory strategy behind a new era of precision medicine.This is a rare opportunity to join a clinical-stage biotech company that's redefining how rare and genetic diseases are treated. As VP/SVP of Regulatory Affairs, you'll be the architect of global regulatory strategy-guiding breakthrough therapies from development to approval and beyond. If you're ready to lead with purpose and build something transformative, this is the move worth making.? Why This Role MattersStrategic Ownership: You'll lead all aspects of regulatory strategy across a growing pipeline of high-impact programs.Executive Visibility: Work directly with the C-suite and Board to shape development timelines, regulatory positioning, and global launch readiness.Patient-Centered Mission: Your leadership will accelerate access to therapies for underserved populations with urgent medical needs.Global Reach: Influence regulatory pathways across the U.S., EU, and other key markets.? What You'll Bring15+ years in Regulatory Affairs, with deep experience in clinical-stage biotechProven success leading INDs, CTAs, BLAs/MAAs, and global regulatory interactionsStrong leadership and communication skills, with the ability to influence internal and external stakeholdersExperience building and scaling regulatory teams and infrastructureA strategic mindset and passion for solving complex regulatory challenges? What You'll DoDevelop and execute global regulatory strategies across multiple therapeutic programsServe as the primary liaison with health authorities, leading key interactions and submissionsBuild and mentor a high-performing regulatory teamPartner cross-functionally to align regulatory strategy with clinical, CMC, and commercial goalsMonitor evolving regulatory landscapes and proactively adapt strategy? What You'll GetExecutive Leadership: A seat at the table where your voice shapes company direction and patient petitive Compensation: Strong base salary, performance bonus, and meaningful equity prehensive Benefits: Health coverage, 401(k) match, stock purchase plan, generous PTO, paid parental leave, and more.Mission-Driven Culture: Join a team united by a shared purpose-delivering transformative therapies to patients who need them most.

Created: 2025-09-24