Director, Global Regulatory Strategy – Biotech

LeonaBio; United States; On-site; USD 180,000 - 260,000; Full time

Job summary

LeonaBio, Inc., based in the Seattle area, is seeking a Director, Regulatory Affairs, Strategy to lead global regulatory strategy for two programs, shaping submissions toward US/EU marketing applications and late‑phase development. This hands-on role partners with executive leadership to identify risks and provide clear recommendations.

The successful candidate will guide health authority engagements from FDA pre‑NDA through EMA Advice, build regulatory infrastructure, and influence

Qualifications

• 8+ years in biopharmaceutical regulatory affairs.
• Led at least one US NDA/BLA submission or readiness activities.
• Experience with FDA meetings as regulatory lead.
• Experience advancing programs from early to late development with health authority alignment.

Responsibilities

• Define global regulatory strategy with target product profiles and labeling.
• Lead US marketing application readiness and post‑approval lifecycle planning.
• Oversee health authority strategy across programs, including EMA and FDA interactions.
• Anticipate regulatory questions and develop contingency approaches.
• Build regulatory infrastructure: submission standards and intelligence.
• Collaborate with cross‑functional teams to inform development decisions.

Skills

Regulatory strategy

Cross-functional leadership

Scientific writing

Influence without authority

AI-enabled regulatory tools

Education

Advanced degree in life sciences

Job description

LeonaBio, Inc., based in the Seattle area, is seeking a Director, Regulatory Affairs, Strategy to lead global regulatory strategy for two programs, shaping submissions toward US/EU marketing applications and late‑phase development. This hands-on role partners with executive leadership to identify risks and provide clear recommendations.

The successful candidate will guide health authority engagements from FDA pre‑NDA through EMA Advice, build regulatory infrastructure, and influence