Director/Senior Director, Global Regulatory Affairs

Title: Director / Senior Director, Global Regulatory Lead

Location: San Francisco, CA or Boston, MA -> hybrid 3-days per week (relocation offered!)

Overview

A growing oncology biotech is seeking a Director / Senior Director, Global Regulatory Lead to drive global regulatory strategy across clinical-stage oncology programs. This individual will play a critical role in leading the company’s first NDA submission and partnering closely with executive leadership to advance assets toward approval.

Key Responsibilities

• Lead global regulatory strategy for oncology programs from late-stage development through approval
• Serve as the regulatory lead for NDA/BLA submissions, including planning, execution, and submission readiness
• Partner cross-functionally with Clinical, CMC, Commercial, and Executive Leadership teams
• Act as the primary point of contact with global health authorities (e.g., FDA, EMA)
• Provide strategic input on regulatory risks, timelines, and pathways
• Oversee regulatory documentation, including briefing books, submission dossiers, and responses to agency queries

Qualifications

• Bachelor’s degree required; advanced degree (PhD, PharmD, MS) preferred
• 10+ years of regulatory affairs experience within biotech/pharma
• Recent, hands-on oncology NDA/BLA submission experience required
• Strong knowledge of global regulatory requirements and pathways
• Proven leadership experience with the ability to influence cross-functional teams
• Experience in a fast-paced or emerging biotech environment preferred