SVP Regulatory Affairs

Vice President / Senior Vice President - Regulatory Affairs
📍 U.S. - Remote or Hybrid (Bay Area) | Full-time
💰 Salary Range: $280,000 - $360,000 + 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 Matters

• Strategic 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 Bring

• 15+ years in Regulatory Affairs, with deep experience in clinical-stage biotech
• Proven success leading INDs, CTAs, BLAs/MAAs, and global regulatory interactions
• Strong leadership and communication skills, with the ability to influence internal and external stakeholders
• Experience building and scaling regulatory teams and infrastructure
• A strategic mindset and passion for solving complex regulatory challenges

🎯 What You'll Do

• Develop and execute global regulatory strategies across multiple therapeutic programs
• Serve as the primary liaison with health authorities, leading key interactions and submissions
• Build and mentor a high-performing regulatory team
• Partner cross-functionally to align regulatory strategy with clinical, CMC, and commercial goals
• Monitor evolving regulatory landscapes and proactively adapt strategy

💼 What You'll Get

• Executive Leadership: A seat at the table where your voice shapes company direction and patient impact.
• Competitive Compensation: Strong base salary, performance bonus, and meaningful equity participation.
• Comprehensive 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.
• Remote Flexibility: Work from anywhere in the U.S. while staying connected to a collaborative, forward-thinking team.