Senior Director, Regulatory Affairs
Septerna
September 15, 2026
Full-time
Remote friendly (South San Francisco, CA)
Worldwide
Corporate Functions
Role: Senior Director of Regulatory Affairs leading regulatory strategy and execution for Septerna's discovery and development programs, focusing on preclinical and clinical stages. Responsibilities: develop and implement regulatory plans, oversee IND/CTA submissions, manage interactions with FDA and global agencies, guide cross-functional teams on regulatory requirements, and ensure compliance across CMC, Nonclinical, and Clinical functions. Qualifications: Bachelor's degree in life sciences or related field; 12+ years in Regulatory Affairs within biopharma, with experience leading IND/CTA submissions and interacting with regulatory agencies. Preferred: advanced degree (PhD, PharmD, MS), prior Global Regulatory Lead experience. High-Value: biopharma, biotech, early to late-stage development, IND/CTA submissions, FDA interactions, global regulatory strategy, experience with GPCR-targeted therapeutics, fast-paced environment, leadership within discovery and clinical programs. WorkSetup: based in South San Francisco, CA; salary range $270K-$295K, with benefits and stock options.