Septerna

Septerna

Director/Senior Director, Regulatory Affairs

South San Francisco, California, United States · Director · Full-time

Sponsorship not specified$235k-$285kDetected 89 days ago
ComplianceProject ManagementFDA RegulatoryResearchAnimal StudiesLeadershipCommunicationCollaborationRegulatory Affairs

About the role

  • 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.
  • Manage interactions with FDA and other global regulatory agencies
  • 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.
  • 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.
  • Manage interactions with FDA and other global regulatory agencies; coordinate and prepare for regulatory meetings.

Requirements

  • 10+ 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.
  • Ability to thrive in a dynamic, fast-paced environment and work effectively across functions.
  • If you are a California resident, click here for our CCPA Notice.
  • Prior experience as a Global Regulatory Lead (GRL) preferred.
  • Excellent project management, organizational, and verbal and written communication skills.
  • High attention to detail and accuracy.
  • Hands-on, strategic thinker with a collaborative and solution-oriented mindset.
  • The anticipated salary range for candidates who will work in South San Francisco, CA is $235,000 - $285,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.

Nice to have

  • Bachelor's degree in life sciences or a related field
  • advanced degree (PhD, PharmD, or MS) preferred.

Compensation

  • The anticipated salary range for candidates who will work in South San Francisco, CA is $235,000 - $285,000.

Benefits

  • 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.
  • 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.
  • Lead the preparation, review, and submission of high-quality regulatory documents, including INDs, CTAs, amendments, briefing packages, and responses to health authority inquiries.

Company info

  • Please do not forward any agency resumes.
  • The company will not be responsible for any fees related to resumes that are unsolicited.
  • We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
  • Septerna participates in the E-Verify program.
  • 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.
  • We are committed to the development of meaningful therapeutics for patients with indications of high unmet need.
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This listing is sourced directly from Septerna's careers page and normalized into a canonical job model.