Global Regulatory Strategy Director

LeonaBio, Inc.; Bothell (WA); On-site; USD 180,000 - 280,000; Full time

Job summary

LeonaBio, Inc. in the Seattle area is seeking a Director, Regulatory Affairs, Strategy to lead global regulatory strategy across two development programs. This hands-on role partners with executive leadership to shape regulatory decisions across clinical development and registration efforts.

The successful candidate combines deep regulatory expertise with strategic thinking, a track record in US/EU submissions, and the ability to influence cross-functional teams in a fast-paced environment.

Qualifications

• Advanced life science degree (PharmD/PhD/MD/MS) with 8+ years in biopharma regulatory affairs.
• Experience owning at least one US marketing application (NDA/BLA) from readiness to submission.
• Direct experience leading FDA meetings as regulatory lead, including briefing authorship.
• Experience carrying a program from early to late development with health authority agreement.
• Working knowledge of ex-US requirements (EU CTR/CTIS, MAA) and other major regions.
• Excellent scientific writing and clear, evidence-based communication.
• Ability to leverage AI-enabled tools to enhance strategy, intelligence, and document authoring.
• Ability to influence cross-functional teams and drive decisions without direct authority.
• Experience balancing regulatory, scientific, operational, and benefit-risk considerations.

Responsibilities

• Own global regulatory strategy for two programs with timelines aligned to clinical, CMC, and program milestones.
• Lead US marketing application readiness through submission-level authoring and sign-off; manage post-approval lifecycle.
• Own health authority strategy across programs, including pre-NDA meetings and EMA Scientific Advice.
• Anticipate regulatory risks and develop proactive, evidence-based positions and contingencies.
• Develop regulatory strategies and engagement plans with objectives, alternatives, and contingencies.
• Lead regulatory work to move early‑phase programs into late‑phase development with a registration-enabling design.
• Serve as primary FDA point of contact and manage ex-US interactions via consultants/partners.
• Influence cross-functional decisions by integrating regulatory considerations into development and operations.
• Represent Regulatory Affairs on program teams and governance forums; review protocols and CSRs.
• Translate regulatory feedback into clear recommendations for technical teams and executives.
• Build core infrastructure: submission standards, regulatory intelligence, and process SOPs.

Skills

Regulatory strategy

FDA meetings

Global development

Writing & comms

AI in regulatory

Cross-functional influence

Education

Advanced degree in life sciences

Tools

Regulatory intelligence tools

Job description

LeonaBio, Inc. in the Seattle area is seeking a Director, Regulatory Affairs, Strategy to lead global regulatory strategy across two development programs. This hands-on role partners with executive leadership to shape regulatory decisions across clinical development and registration efforts.

The successful candidate combines deep regulatory expertise with strategic thinking, a track record in US/EU submissions, and the ability to influence cross-functional teams in a fast-paced environment.