Job Description
📋 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
