About Stoke

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 https://www.stoketherapeutics.com/

Position Purpose

The Vice President, Regulatory Strategy & CMC is responsible for leading teams to develop and execute global regulatory and Chemistry, Manufacturing & Controls (CMC) strategies across the company's product portfolio. This leader provides strategic direction for regulatory interactions, product development, manufacturing, quality, and commercialization activities to support clinical development, regulatory approvals, and lifecycle management.

The VP will lead cross-functional collaboration across Regulatory Affairs, Technical Operations, CMC , Quality, Clinical Development, Supply Chain, and external partners to ensure successful advancement of programs from early development through commercialization. The role serves as the primary executive advisor on regulatory and CMC risks, opportunities, and policy considerations impacting corporate strategy.

Key Responsibilities

Regulatory Strategy Leadership

Provide oversight and guidance into development and implementation of integrated global regulatory strategies for Stoke programs.
Lead and manage teams responsible for INDs, CTAs, IMPDs, BLAs, NDAs, MAAs, and post-approval submissions.
Serve as the executive lead for interactions with FDA, EMA, MHRA, PMDA, Health Canada, and other global regulatory agencies.
Provide strategic regulatory guidance to executive leadership and program teams regarding development pathways, agency expectations, accelerated programs, and risk mitigation.
Monitor evolving regulatory requirements and assess impacts on development and commercial programs.
Support corporate business development, licensing, due diligence, and portfolio evaluation activities.

CMC Strategy & Technical Operations

Provide oversight and guidance into enterprise-wide CMC strategies for drug substance, drug product, analytical development, process development, manufacturing, supply, and combination drug-device development.
Ensure phase-appropriate CMC development plans are aligned with regulatory expectations and business objectives.
Lead and manage teams responsible for CMC readiness activities supporting clinical studies, registration, launch, and lifecycle management.
Partner with Quality and Technical Operations to ensure compliance with cGMP, ICH, FDA, EMA, and global regulatory requirements.
Provide strategic regulatory guidance on long-range manufacturing and supply strategies to support global commercial expansion.

Organizational Leadership

Build, mentor, and lead high-performing Regulatory Strategy and CMC teams.
Establish department goals, governance processes, resource planning, and budget management.
Foster a collaborative, science-driven, and compliance-focused culture.
Influence company strategy through participation on executive leadership committees and governance boards.
Manage external consultants, CROs, CDMOs, and strategic partnerships supporting regulatory and manufacturing activities.

Commercialization & Lifecycle Management

Support launch readiness activities and commercial regulatory strategies.
Oversee post-approval changes, global lifecycle management activities, and market expansion initiatives.