Director/senior Director, Regulatory Affairs

Septerna

South San Francisco, California, United States
Base: $235,000 - $285,000; bonus/equity: annual ta...
On-site
10+ years regulatory affairs experience
Direct ind and cta submission leadership
Fda and global agency interaction experience
Septerna is seeking a Director/Senior Director of Regulatory Affairs to lead regulatory strategy and execution for its drug discovery programs in South San Francisco, California. The ideal candidate will have extensive regulatory experience, particularly with IND and CTA submissions, and will thrive in a fast-paced biotech environment

Job Summary

  • Septerna is a biotechnology company focused on developing life-changing medicines using its Native Complex Platform to target G protein-coupled receptors.
  • The successful candidate will lead regulatory strategies for clinical stage programs and manage high-quality submissions including INDs and CTAs.
  • The role offers a competitive salary range of $235,000 to $285,000 along with stock options and an annual target bonus.

Matching Summary

Match Score: 85

Septerna is seeking a Director/Senior Director of Regulatory Affairs to lead regulatory strategy and execution for its drug discovery programs in South San Francisco, California. The ideal candidate will have extensive regulatory experience, particularly with IND and CTA submissions, and will thrive in a fast-paced biotech environment.

Salary

Base: $235,000 - $285,000; Bonus/Equity: Annual target bonus and stock options included; Benefits: Full-time benefits package provided

Skills & Requirements

Must-have

  • 10+ years Regulatory Affairs experience
  • Direct IND and CTA submission leadership
  • FDA and global agency interaction experience

Nice-to-have

  • Global Regulatory Lead (GRL) experience
  • PhD or PharmD advanced degree preferred
  • Mentoring junior regulatory staff

Key Requirements

  • Bachelor's degree in life sciences required
  • 10+ years in biopharmaceutical Regulatory Affairs
  • Proven track record with FDA interactions

Work Rights

Not specified

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