Director, Regulatory Affairs

Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life‑changing medicines for patients with the vision to become the industry‑leading G protein‑coupled receptor (GPCR)-focused drug discovery company. The company’s Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context, providing novel access to modern structural and screening technologies for the entire class of GPCRs.

Septerna has an emerging pipeline of GPCR‑targeted small molecule programs with potential to address many undruggable and unexploited targets.

We are building a multidisciplinary team dedicated to creating revolutionary medicines to address unmet patient needs. At Septerna we embrace diversity of thought, expertise, and background through collaboration, encouraging everyone to bring their authentic selves to work every day. We cultivate an environment where teams learn from each other and work together to pursue ground-breaking innovations.

This is a tremendous opportunity to work with talented individuals on the front lines of therapeutic discovery and development. You will directly help move therapies through preclinical research and position them for success in the clinic. The successful candidate will contribute passion, unique talents, and expertise to a dynamic team motivated to discover new disease‑modifying therapeutics for patients in a fast‑paced environment.

• 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.

• Bachelor’s degree in life sciences or a related field; advanced degree (PhD, Pharm
  
  D, or MS) preferred.
• Prior experience as a Global Regulatory Lead (GRL) preferred.
• 10+ 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.

Salary: $235,000 – $260,000 (South San Francisco, CA). Individual pay may vary based on additional factors including job‑related skills, experience, work location, and relevant education or training. The compensation package also includes benefits, stock options, and annual target bonus for full‑time positions.

Equal Employment Opportunity Statement: Septerna participates in the E‑Verify program. We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.