Job Description
📋 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
