Director, Global Regulatory Strategy (Hybrid)

Stoke Therapeutics; Tennessee; Hybrid; USD 248,000 - 280,000; Full time

Benefits offered by this job

Annual bonus

Equity participation

Medical/dental/vision

401K with company match

Unlimited vacation

Tuition assistance

ESPP

Job summary

Stoke Therapeutics seeks a Director of Global Regulatory Strategy to lead regulatory planning across programs, ensuring alignment with corporate goals and timelines. You will partner with R&D, clinical development, and manufacturing to shape submissions and interactions with health authorities.

Ideal candidates have 8+ years in regulatory affairs, experience with rare diseases, and a track record of major submissions.

Qualifications

• 8+ years minimum Regulatory Affairs experience in the pharmaceutical industry.
• MS, MS or PhD in a scientific discipline preferred.
• Experience in rare disease drug development and neurology indications preferred.
• Experience in preparing major regulatory submissions and interfacing with regulators.

Responsibilities

• Defines and drives regulatory strategy for assigned activities/programs.
• Represents RA in internal teams to align regulatory plans with business objectives and timelines.
• Anticipates regulatory risks and develops mitigation strategies and educates stakeholders.
• Oversees preparation and submission of global regulatory submissions to support programs.

Skills

Regulatory affairs experience

Rare disease drug development

Interfacing with regulators

Excellent communication

Leadership / people management

Analytical thinking

Education

MS or PhD in scientific discipline

Job description

Stoke Therapeutics seeks a Director of Global Regulatory Strategy to lead regulatory planning across programs, ensuring alignment with corporate goals and timelines. You will partner with R&D, clinical development, and manufacturing to shape submissions and interactions with health authorities.

Ideal candidates have 8+ years in regulatory affairs, experience with rare diseases, and a track record of major submissions.