Global Regulatory Strategy Director (Hybrid)

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Parental leave

401K with company match

Unlimited vacation

Tuition assistance

ESPP

Job summary

Stoke Therapeutics, headquartered in Bedford, MA, seeks a Director of Global Regulatory Strategy to lead regulatory planning across programs and align with corporate objectives. The role partners with cross-functional teams and reports to the Executive Director, Global Regulatory Strategy.

The position requires extensive RA experience, strong communication, and ability to drive regulatory plans through FDA and other authorities, with a hybrid work model in Massachusetts.

Qualifications

• 8+ years of Regulatory Affairs experience in pharma.
• Experience in rare disease drug development preferred.
• Interfacing with regulatory authorities and preparing submissions.

Responsibilities

• Defines and drives regulatory strategy for assigned programs.
• Represents RA in internal teams to align plans with timelines.
• Leads preparation and submission of global regulatory submissions.
• Manages regulatory agency interactions and meetings.
• Keeps policies and SOPs aligned with compliant culture.

Skills

Regulatory strategy

Regulatory submissions

Leadership

Stakeholder management

Cross-functional collaboration

Education

BS/MS/PhD in science

Job description

Stoke Therapeutics, headquartered in Bedford, MA, seeks a Director of Global Regulatory Strategy to lead regulatory planning across programs and align with corporate objectives. The role partners with cross-functional teams and reports to the Executive Director, Global Regulatory Strategy.

The position requires extensive RA experience, strong communication, and ability to drive regulatory plans through FDA and other authorities, with a hybrid work model in Massachusetts.