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Job description
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
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Worksite address
boston, MA, 02298, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.