Director/Senior Director, Regulatory Affairs

Septerna is seeking an experienced and highly motivated Director/Senior Director of Regulatory Affairs to lead regulatory strategy and execution across discovery and development programs.

Requirements

• Develop and implement regulatory strategies for clinical stage programs, ensuring alignment with business and development objectives.
• Serve as the primary Regulatory Affairs representative on project teams, providing guidance on regulatory requirements and pathways.
• Lead the preparation, review, and submission of high-quality regulatory documents, including INDs, CTAs, amendments, briefing packages, and responses to health authority inquiries.
• Manage interactions with FDA and other global regulatory agencies; coordinate and prepare for regulatory meetings.
• Partner with CMC, Nonclinical, and Clinical teams to ensure compliance with applicable regulations and consistent messaging across submissions.
• Identify regulatory risks and proactively work with cross-functional teams to develop mitigation strategies.
• Monitor the evolving regulatory landscape and communicate implications for Septerna’s programs.
• Support the development of internal regulatory processes, systems, and documentation to enable scalability as the organization grows.
• Mentor and develop junior regulatory staff and contribute to a culture of collaboration and excellence.

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Health Insurance
• Stock Options
• Annual Target Bonus