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 #J-18808-Ljbffr