Sobre este puesto de Senior Director, Regulatory Affairs en Septerna
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. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date.
We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team.
We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment.
For more information see: www.septerna.com.
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.
