Director/Senior Director of Regulatory Affairs

About the Company

Pathos is building a next-generation biotech with AI at the core. We are building the largest foundation model in oncology and pairing it with proprietary AI systems and deep oncology expertise to make drug development decisions with more precision, much earlier.

Responsibilities

• Own the full IND lifecycle for the oncology pipeline, including authoring IND amendments, annual reports, and DSUR development
• Oversee eCTD publishing and submission infrastructure, ensuring all packages are accurate and inspection-ready
• Build and maintain SOPs, controlled document systems, and records management infrastructure
• Work with software and ML engineering teams to build AI-powered systems that accelerate regulatory execution
• Direct AI agents to generate regulatory document drafts and flag inconsistencies
• Serve as the primary sponsor representative with the FDA, leading preparation for pre-IND, Type B, Type C, and End of Phase meetings

Requirements

• 10+ years of regulatory affairs experience in biotech or pharmaceutical development
• Deep oncology experience
• Direct IND lifecycle management experience (authoring DSURs, IB updates, and FDA meeting packages)
• Proven experience as an accountable FDA sponsor representative
• Experience as a first or early regulatory hire at a small or growth-stage biotech
• Comfort working alongside software and ML engineers to build and iterate on AI-driven systems
• Active engagement with the evolving regulatory landscape for AI-enabled drug development

Preferred Qualifications

• Familiarity with precision medicine and biomarker-driven oncology programs
• Familiarity with innovative trial designs or AI-enabled development approaches