Vice President, Regulatory Strategy and CMC

Stoke Therapeutics seeks a Vice President to lead regulatory strategy and CMC functions across its antisense oligonucleotide pipeline. This executive will oversee global regulatory submissions, agency interactions, and manufacturing operations while advising leadership on regulatory risks and development pathways.

Responsibilities

• Develop and execute integrated global regulatory strategies for company product programs
• Lead regulatory teams managing INDs, CTAs, BLAs, NDAs, MAAs, and post-approval submissions
• Serve as executive lead for FDA, EMA, MHRA, PMDA, and other regulatory agency interactions
• Oversee CMC strategy, manufacturing readiness, and technical operations alignment with regulations
• Advise executive leadership on regulatory pathways, accelerated programs, and risk mitigation

Requirements

• Extensive experience leading regulatory affairs teams and CMC strategy in biopharmaceuticals
• Demonstrated expertise with IND, BLA, NDA, and MAA submissions to global agencies
• Strong knowledge of FDA, EMA, and international regulatory requirements for drug development
• Leadership experience in chemistry, manufacturing, controls, and technical operations
• Track record of cross-functional collaboration in clinical development and commercialization
• Understanding of antisense or advanced modality drug development preferred