Senior Manager, Regulatory Affairs, CMC

Stoke Therapeutics

Stoke Therapeutics seeks a Senior Manager of Regulatory Affairs focused on Chemistry, Manufacturing, and Controls (CMC). This role directs global CMC regulatory strategy, leads lifecycle management, and provides cross-functional guidance for multiple development and commercial programs.

Responsibilities

Develop and execute global CMC regulatory strategies for development and commercial programs
Lead authoring of Quality Modules and manage document review and approval workflows
Assess change controls and technical information for regulatory impact and compliance
Establish tracking processes for dossier lifecycle, health authority questions, and post-approval commitments
Build and maintain relationships across Regulatory Affairs and Technical Operations teams

Requirements

BS/BA in scientific, pharmaceutical, or engineering discipline; advanced degree preferred
Minimum 8 years industry experience with 5+ years directly in CMC Regulatory Affairs
Demonstrated success developing regulatory strategies in US and EU markets
Experience with commercial-phase programs and post-approval CMC requirements
Deep knowledge of ICH, FDA, and EMA regulations; Module 3 expertise
Authoring experience with Quality Modules 2.3 and 3; health authority submissions
Background in manufacturing, process development, validation, or analytical development

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Vacancy posted 2 days ago

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