US Regulatory Strategy Lead

📋 Description

• Lead US regulatory strategy for assigned development and marketed products
• Partner with Global Regulatory Team and participate in cross-functional project teams
• Present US regulatory position to stakeholders and guide expedited pathways when possible
• Develop US regulatory strategies with risk assessments and mitigation plans
• Prepare teams for FDA meetings and lead major agency meetings
• Coordinate with regulatory consultants and internal departments for timely submissions

🎯 Requirements

• BS in a scientific discipline; advanced degree preferred
• 6+ years regulatory affairs experience with FDA meetings; major application delivery is a plus
• Experience in immunology or related late-stage development is favorable
• Strong leadership, teamwork, and communication skills
• Fluent in English; strong written and verbal communication

🎁 Benefits

• Competitive compensation and generous time off
• Conference attendance opportunities and work/life balance focus
• Collaborative, team-oriented environment and mission to help ultra-rare diseases
• Equal opportunity employer with accommodation process available