Senior Director, Regulatory Affairs

About the Role

Septerna is seeking an experienced and highly motivated Senior Director of Regulatory Affairs to lead regulatory strategy and execution across our discovery and development programs. This individual will be responsible for developing and implementing regulatory plans and submissions to support preclinical and clinical development, IND/CTA submissions, and interactions with global health authorities. The ideal candidate will bring deep regulatory expertise, strong cross-functional leadership, and a proactive, strategic mindset suited to a fast-paced biotech environment. This position reports into the VP, Regulatory Affairs.

Responsibilities 

• 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.

Qualifications

• Bachelor’s degree in life sciences or a related field; advanced degree (PhD, PharmD, or MS) preferred.
• Prior experience as a Global Regulatory Lead (GRL) preferred.
• A minimum of 15+ years of experience in Regulatory Affairs within the biopharmaceutical industry, including direct experience leading IND and/or CTA submissions.
• Proven track record of successful interactions with the FDA and other global regulatory agencies.
• Strong understanding of drug development processes, from discovery through clinical stages.
• Excellent project management, organizational, and verbal and written communication skills.
• High attention to detail and accuracy.
• Ability to thrive in a dynamic, fast-paced environment and work effectively across functions.
• Hands-on, strategic thinker with a collaborative and solution-oriented mindset.

The anticipated salary range for candidates who will work in South San Francisco, CA is $270,000 - $295,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.