Director, Global Regulatory Affairs

Stoke Therapeutics seeks a Director of Global Regulatory Affairs to develop and execute regulatory strategies for its RNA medicine portfolio. The role leads regulatory planning across programs, manages FDA interactions, and oversees submissions while aligning development with corporate objectives.

Responsibilities

• Define and drive regulatory strategy for assigned programs and activities
• Represent regulatory affairs on internal cross-functional teams to align plans with business goals
• Identify regulatory risks and develop mitigation strategies for stakeholder education
• Serve as primary regulatory contact with FDA and other health authorities
• Oversee preparation and submission of global regulatory filings for development and registration

Requirements

• 8+ years pharmaceutical regulatory affairs experience
• Bachelor's degree or higher in scientific discipline
• Experience with rare disease drug development
• Neurology indication experience preferred
• Track record preparing major regulatory submissions and amendments
• Direct FDA and regulatory authority interface experience
• Strong written, verbal, and negotiation skills