Director, Regulatory Affairs (San Francisco)

Septerna – Director of Regulatory Affairs

Septerna is a biotechnology company based in South San Francisco, CA, focused on developing life‑changing medicines. We aim to become the industry‑leading GPCR‑focused drug discovery company.

Pay Range

$235,000.00/yr – $260,000.00/yr

About the Role

We are seeking an experienced and highly motivated Director of Regulatory Affairs to lead regulatory strategy and execution across our discovery and development programs. This individual will develop and implement regulatory plans and submissions to support preclinical and clinical development, IND/CTA submissions, and interactions with global health authorities. The position reports to 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.
• 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.

Seniority Level

Mid‑Senior level

Employment Type

Full‑time

Job Function

Legal

Industries

Biotechnology Research and Pharmaceutical Manufacturing

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.

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