Strategic Director, Global Regulatory Strategy

Stoke Therapeutics; Bedford (MA); Hybrid; USD 248,000 - 280,000; Full time

Benefits offered by this job

Medical/Dental/Vision insurance

Life & Disability insurance

Parental leave

401K with company match

Unlimited vacation

Tuition assistance

ESPP

Job summary

Stoke Therapeutics seeks a Director of Global Regulatory Strategy to lead global regulatory planning, ensuring products move through development, approval, and maintenance in line with health authority expectations.

The role reports to the Executive Director and requires coordinating with cross-functional teams, managing regulatory risk, and driving strategy across programs, with a hybrid schedule in Bedford/Will be based in Waltham.

Qualifications

• 8+ years of Regulatory Affairs experience in the pharmaceutical industry.
• S., M.S. or Ph.D. in a scientific discipline preferred.
• Experience in rare disease drug development and neurology indications ideal.
• Experience in the preparation of major regulatory submissions and interfacing with relevant regulatory authorities.

Responsibilities

• Defines and drives regulatory strategy for assigned activities/programs.
• Represents RA in internal teams to align regulatory plans with business objectives and development timelines.
• Anticipates regulatory risks and design mitigation strategies; educates stakeholders about risk.
• Serves as primary contact for assigned projects with the FDA and other regulatory agencies as needed.
• Plans and executes successful regulatory agency meetings and interactions.
• Oversee preparation and submission of global regulatory submissions to support program development, registration and maintenance activities.
• Contributes to continuous improvement of processes and policies to establish regulatory compliance.

Skills

Regulatory Affairs

Communication skills

Negotiation skills

Interpersonal skills

Analytical thinking

Education

Advanced degree in science

Job description

Stoke Therapeutics seeks a Director of Global Regulatory Strategy to lead global regulatory planning, ensuring products move through development, approval, and maintenance in line with health authority expectations.

The role reports to the Executive Director and requires coordinating with cross-functional teams, managing regulatory risk, and driving strategy across programs, with a hybrid schedule in Bedford/Will be based in Waltham.