Director/Senior Director, Global Regulatory Affairs (San Francisco Bay Area)
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
Please apply for full company information and job description!
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