Director/Senior Director, Regulatory Affairs

Responsibilities

• Develop and implement regulatory strategies for clinical stage programs
• Serve as the primary Regulatory Affairs representative on project teams
• Lead the preparation, review, and submission of high-quality regulatory documents including INDs and CTAs
• Manage interactions with FDA and other global regulatory agencies
• Partner with CMC, Nonclinical, and Clinical teams to ensure compliance
• Identify regulatory risks and develop mitigation strategies
• Monitor the evolving regulatory landscape
• Support the development of internal regulatory processes and systems
• Mentor and develop junior regulatory staff

Requirements

• Bachelor’s degree in life sciences or a related field
• 10+ years of experience in Regulatory Affairs within the biopharmaceutical industry
• Direct experience leading IND and/or CTA submissions
• Proven track record of successful interactions with the FDA and global regulatory agencies
• Strong understanding of drug development processes from discovery through clinical stages
• Excellent project management and communication skills

Preferred Qualifications

• Advanced degree (PhD, PharmD, or MS)
• Prior experience as a Global Regulatory Lead (GRL)

About the Company

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.