SVP Regulatory Affairs

EPM Scientific have partnered with 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.

Responsibilities: 

• 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

Experience/Requirements:

• 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's on offer:

• 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.