Vice President, Regulatory Strategy and CMC

Stoke Therapeutics•Bedford, MA

6d•$345,000 - $395,000•Hybrid

About The Position

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.

Requirements

Ph.D., Pharm.D., M.S., or advanced scientific degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, Biotechnology, or related discipline preferred.
12+ years of progressive experience in biotechnology, pharmaceutical, or cell and gene therapy industries, with at least 6 years in a leadership capacity.
Deep expertise in global Regulatory Affairs and CMC development.
Demonstrated success leading major regulatory submissions and health authority interactions.
Experience advancing products from early development through commercialization.
Significant experience managing multiple development programs.
Proven executive leadership experience building and managing multidisciplinary teams.
Executive presence and ELT-level communication
Risk assessment and decision-making
Cross-functional influence and collaboration
Change management and organizational leadership
Negotiation and stakeholder management
Financial and operational planning

Responsibilities

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.
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.
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.
Support launch readiness activities and commercial regulatory strategies.
Oversee post-approval changes, global lifecycle management activities, and market expansion initiatives.
Ensure regulatory compliance throughout the product lifecycle while enabling operational flexibility and business growth.
Identify regulatory and manufacturing risks and develop proactive mitigation strategies.