Remote Regulatory CMC Lead, Global Strategy

Stoke Therapeutics; United States; Hybrid; USD 145,000 - 160,000; Full time

Benefits offered by this job

Annual bonus

Equity participation

401K plan with company match

Unlimited vacation time

Tuition assistance

Employee Stock Purchase Program (ESPP)

Job summary

Stoke Therapeutics is seeking a Regulatory CMC Manager to support global regulatory strategies, lifecycle management, and cross-functional regulatory guidance for multiple programs. The role reports to the Director of Regulatory CMC and offers hybrid/remote work in the US.

The candidate will lead authorship of Quality Modules, manage review workflows, and ensure regulatory alignment across US and EU markets. Strong communication and Veeva RIM familiarity are required.

Qualifications

• BS/BA in scientific, pharmaceutical or engineering discipline; advanced degree preferred.
• Minimum of 8 years of industry experience, including a minimum of 5 years directly in CMC Regulatory Affairs.
• Direct experience developing and implementing successful regulatory strategies in both US and EU markets.
• Direct experience with commercial phase programs and post-approval CMC requirements and implementation of regulatory milestones (e.g., Annual Reports).
• Deep understanding of Module 3 sections and associated ICH, FDA, EMA regulations and guidance documents.
• Experience authoring Quality Modules 2.3 and 3; and health authority engagement content (e.g., FDA Briefing Books).
• Practical experience in manufacturing, process development, validation, analytical development, or quality.
• Understanding of technical operations functions and systems including change controls.
• Strong oral and written communication skills.
• Direct experience with Veeva RIM.

Responsibilities

• Prepares and executes global regulatory CMC strategy for development programs and future commercial programs.
• Lead author, and collaborate with SMEs, for Quality Modules and manage document review workflows.
• Analyzes and interprets technical information for regulatory impact and decisions.
• Assesses change controls for regulatory impact and manages the implementation system for regulatory compliance.
• Develops processes to track dossier lifecycle management and post-approval commitments.
• Develops and implements documents, policies, and procedures for regulatory operational alignment.
• Builds and maintains relationships within Regulatory Affairs and Technical Operations teams.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory writing

Global regulatory experience

Oral and written communication

US & EU regulatory knowledge

Strategic thinking

Education

BS/BA in scientific, pharmaceutical or engineering

Advanced degree preferred

Tools

Veeva RIM

Job description

Stoke Therapeutics is seeking a Regulatory CMC Manager to support global regulatory strategies, lifecycle management, and cross-functional regulatory guidance for multiple programs. The role reports to the Director of Regulatory CMC and offers hybrid/remote work in the US.

The candidate will lead authorship of Quality Modules, manage review workflows, and ensure regulatory alignment across US and EU markets. Strong communication and Veeva RIM familiarity are required.