Global CMC Regulatory Strategy Lead (Remote)

Stoke Therapeutics; United States; Hybrid; USD 181,000 - 213,000; Full time

Benefits offered by this job

Annual bonus

Equity participation

Comprehensive benefits

Job summary

Stoke Therapeutics seeks a Regulatory CMC Senior Manager to guide global regulatory CMC strategy across development and future commercial programs. You will lead authoring of Quality Modules and coordinate cross-functional reviews to ensure regulatory readiness.

Ideal candidates bring 8+ years in industry with 5+ years in CMC Regulatory Affairs, plus experience with US/EU regulatory expectations and post-approval activities. Hybrid/remot e work options available in MA.

Qualifications

• BS/BA in scientific, pharmaceutical or engineering field; advanced degree preferred.
• Minimum 8 years in industry; at least 5 years in CMC Regulatory Affairs.
• Experience with US and EU regulatory strategies for development and post-approval.
• Experience authoring Quality Modules 2.3 and 3; and health authority engagement content.

Responsibilities

• Prepares and executes global regulatory CMC strategy for development and future commercial programs.
• Lead author for Quality Modules; manage review and approval workflows.
• Analyzes regulatory information for impact on strategy and decisions.
• Assess change controls for regulatory impact and manage compliance systems.
• Develops lifecycle management processes for regulatory dossiers and post-approval commitments.
• Develops procedures for regulatory operations alignment and efficiency.
• Collaborates within Regulatory Affairs and Technical Operations teams.

Skills

CMC Regulatory Affairs

Regulatory Strategy

Veeva RIM

FDA Guidance

EMA Guidance

Quality Modules

Documentation

Communication

Education

Bachelor's degree in scientific/engineering field

Advanced degree preferred

Job description

Stoke Therapeutics seeks a Regulatory CMC Senior Manager to guide global regulatory CMC strategy across development and future commercial programs. You will lead authoring of Quality Modules and coordinate cross-functional reviews to ensure regulatory readiness.

Ideal candidates bring 8+ years in industry with 5+ years in CMC Regulatory Affairs, plus experience with US/EU regulatory expectations and post-approval activities. Hybrid/remot e work options available in MA.