Director/Senior Director, Global Regulatory Affairs

Title: Director / Senior Director, Global Regulatory LeadLocation: 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 approvalServe as the regulatory lead for NDA/BLA submissions, including planning, execution, and submission readinessPartner cross-functionally with Clinical, CMC, Commercial, and Executive Leadership teamsAct as the primary point of contact with global health authorities (e.g., FDA, EMA)Provide strategic input on regulatory risks, timelines, and pathwaysOversee regulatory documentation, including briefing books, submission dossiers, and responses to agency queriesQualifications:Bachelor's degree required; advanced degree (PhD, PharmD, MS) preferred10+ years of regulatory affairs experience within biotech/pharmaRecent, hands-on oncology NDA/BLA submission experience requiredStrong knowledge of global regulatory requirements and pathwaysProven leadership experience with the ability to influence cross-functional teamsExperience in a fast-paced or emerging biotech environment preferredPlease apply for full company information and job description!

Created: 2026-05-09