US Regulatory Strategy lead

📋 Description

• Lead US regulatory strategy for assigned development and marketed products
• Partner with Global Regulatory Lead and participate in cross-functional teams
• Present US regulatory position to Sobi stakeholders
• Develop US regulatory strategies including risk assessments
• Champion expedited pathways for accelerated patient access
• Prepare and lead major FDA meetings and respond to FDA information requests

🎯 Requirements

• BS in a scientific discipline; advanced degree preferred
• 6+ years regulatory affairs experience with FDA meetings
• Experience delivering major applications (NDA/BLA or sNDA/sBLA)
• Immunology experience welcomed but not required
• Strong leadership, teamwork, and communication skills
• Fluent English written and verbal communication

🎁 Benefits

• Competitive compensation
• Generous time off policy
• Opportunities to attend conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment