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Septerna · 1 day ago

Director, Regulatory Affairs

San Francisco Bay Area

Full-time

Onsite

Director/Executive

$235K/yr - $260K/yr

10+ years exp

Septerna is a biotechnology company based in South San Francisco, CA, focused on developing life-changing medicines through innovative drug discovery. The Director of Regulatory Affairs will lead regulatory strategy and execution for clinical programs, ensuring compliance with regulatory requirements and managing interactions with health authorities.

BiotechnologyInformation TechnologyMedicalSoftware

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

Qualification

Regulatory AffairsIND submissionsCTA submissionsDrug development processesProject managementCommunication skillsAttention to detailStrategic thinkingCollaboration