Senior Director of Regulatory Strategy & Submissions

Septerna; South San Francisco (CA); Sur place; USD 270 000 - 295 000; Plein temps

Avantages offerts par ce poste

Stock options

Annual bonus

Benefits package

Résumé du poste

Septerna in South San Francisco, CA seeks an experienced Senior Director of Regulatory Affairs to lead regulatory strategy across discovery and development programs. You will drive IND/CTA submissions, interact with FDA and global health authorities, and partner with CMC, Nonclinical, and Clinical teams to align messaging.

Ideal candidate has 15+ years in Regulatory Affairs within biopharma, plus a proven track record with global agencies and a collaborative, proactive leadership style.

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• 15+ years regulatory affairs experience in biopharma.
• Proven track record with FDA and global agencies.
• Experience leading IND/CTA submissions.
• Strong project management and communication skills.

Responsabilités

• Develop regulatory strategies for clinical stage programs.
• Lead Regulatory Affairs representative on project teams.
• Prepare, review, and submit INDs, CTAs, amendments, briefing packages.
• Manage interactions with FDA and global regulatory agencies.
• Partner with CMC, Nonclinical, and Clinical teams for regulatory alignment.
• Identify regulatory risks and mitigation strategies.
• Monitor evolving regulatory landscape and communicate implications.
• Support development of internal regulatory processes and systems.
• Mentor and develop junior regulatory staff.

Connaissances

Global Regulatory Lead

Regulatory strategy

IND/CTA submissions

Cross-functional leadership

Regulatory compliance

FDA interactions

Formation

Bachelor’s in life sciences

PhD/PharmD/MS preferred

Description du poste

Septerna in South San Francisco, CA seeks an experienced Senior Director of Regulatory Affairs to lead regulatory strategy across discovery and development programs. You will drive IND/CTA submissions, interact with FDA and global health authorities, and partner with CMC, Nonclinical, and Clinical teams to align messaging.

Ideal candidate has 15+ years in Regulatory Affairs within biopharma, plus a proven track record with global agencies and a collaborative, proactive leadership style.