Senior Manager, Regulatory Affairs, CMC

Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study.

Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit

Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study.

Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit

The Regulatory CMC Senior Manager is responsible for contributing to the development of Stoke’s products by supporting global CMC regulatory strategies, leading lifecycle management initiatives, and providing regulatory guidance to cross-functional teams for multiple programs. This position will report to the Director of Regulatory CMC.

• Prepares and executes global regulatory CMC strategy for development programs and future commercial programs, including new applications, information amendments, annual reports, supplements/ variations, and responses to health authority questions.
• Lead author, and able to collaborate with Subject Matter Experts, for Quality Modules. Effectively manage document review and approval workflows.
• Analyzes and interprets technical information for impact to regulatory strategy and decisions
• Assesses change controls for regulatory impact and manages the implementation system for regulatory compliance
• Develops process(es) to track regulatory dossier lifecycle management, health authority questions, and post approval commitments, as needed
• Develops and implements documents, policies, and/or procedures for regulatory operational alignment and efficiencies
• Builds and maintains relationships within the Regulatory Affairs department and Technical Operations (CMC) teams

• BS/ BA degree 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…