Head of Regulatory Affairs

Pathos • New York, NY

16d • Hybrid

About The Position

Pathos is seeking a Head of Regulatory Affairs to lead the regulatory function across the organization. This individual will own regulatory strategy and execution across our oncology pipeline and serve as the primary sponsor representative to the FDA.
This is a strategic and hands-on role. In a small and growing biotech, you will define regulatory strategy while directly leading core IND lifecycle activities, regulatory submissions, and agency interactions.

Requirements

• 12+ years of regulatory affairs experience in biotech or pharmaceutical development
• Deep experience in oncology drug development
• Direct IND lifecycle management experience
• Demonstrated experience serving as sponsor representative to FDA
• Hands-on experience authoring: DSURs IND amendments and annual reports Investigator’s Brochure updates FDA meeting packages
• Experience overseeing eCTD submissions
• Familiarity with ClinicalTrials.gov reporting requirements
• Excellent written and verbal communication skills

Nice To Haves

• Experience in a small or growing biotech environment
• Experience with precision medicine or biomarker-driven programs
• Familiarity with innovative trial designs or AI-enabled development approaches

Responsibilities

• Serve as the primary sponsor representative and day-to-day FDA contact
• Manage regulatory correspondence and information requests
• Lead preparation and authorship of FDA meeting packages (e.g., pre-IND, Type B/C, EOP meetings)
• Represent Pathos in health authority interactions
• Own ongoing maintenance of active INDs across their full lifecycle
• Prepare and submit IND amendments and annual reports
• Lead cross-functional authorship of DSURs (in collaboration with Safety, Biostatistics, and Data Management)
• Oversee and author Investigator’s Brochure (IB) updates
• Oversee eCTD publishing (directly or via management of an external publishing vendor)
• Ensure submission quality, completeness, and timeliness
• Maintain regulatory submission timelines and infrastructure
• Manage ClinicalTrials.gov listings and reporting
• Ensure regulatory compliance and inspection readiness
• Develop regulatory strategies aligned with clinical development goals
• Advise leadership on regulatory risks and pathway considerations
• Support planning for future NDA/BLA strategy as programs advance

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: No Education Listed