Director, Regulatory CMC

Company Overview

Dyne Therapeutics focuses on delivering functional improvement for people living with genetically driven neuromuscular diseases. We develop therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.

The mission is to deliver functional improvement for individuals, families and communities.

The Director, Regulatory Affairs – Chemistry, Manufacturing, and Controls (CMC) defines and executes global CMC regulatory strategies for Dyne programs across all stages of development, through and beyond product approval. This role plays a critical leadership role in enabling clinical registration, commercial readiness, and manufacturing lifecycle management by ensuring high-quality, compliant, and strategically aligned CMC regulatory submissions worldwide. The director is a key strategic partner to Manufacturing, Quality, Clinical Operations, Program Teams, and the broader Regulatory organization, providing expert regulatory guidance, risk assessment, and leadership across early- and late-stage programs.

The role operates with a high degree of independence and influence, contributing to program-level decision-making and organizational regulatory excellence. This role is based in Waltham, MA.

• Lead and execute global CMC regulatory strategies for assigned programs across all phases of development, including IND, IMPD, BLA/MAA, and post-approval lifecycle management.
• Serve as the CMC regulatory strategist and program leader, proactively identifying regulatory risks, opportunities, and mitigation strategies in alignment with development and commercialization objectives.
• Provide strategic regulatory guidance to Manufacturing and Quality organizations to ensure global compliance and readiness for clinical and commercial supply.
• Oversee the planning, development, and delivery of high-quality CMC sections for global regulatory submissions and responses to Health Authority questions, including clinical and commercial manufacturing changes.
• Ensure alignment of CMC regulatory content with evolving regulatory expectations, guidance, and policy trends across regions.
• Coordinate and manage global regulatory submissions, maintenance of product registrations, and change control activities throughout the product lifecycle.
• Act as the primary CMC Regulatory Affairs point of contact for cross-functional teams, providing clear direction on global regulatory requirements, timelines, and risks.
• Represent Regulatory CMC in program, functional, and governance meetings, influencing decision-making without direct authority.
• Partner closely with Manufacturing, Quality, Clinical Operations, and Program Management to deliver critical regulatory milestones.
• Drive execution of regulatory policies, processes, and best practices to ensure consistent, compliant, and efficient regulatory operations.
• Leverage deep technical and regulatory expertise to anticipate challenges and enable proactive problem-solving.
• Mentor and support the development of regulatory team members, fostering a culture of collaboration, accountability, and continuous learning.
• Contribute to the advancement of Dyne’s regulatory capabilities by sharing knowledge, lessons learned, and regulatory insights across the organization.

• Bachelor’s degree in life sciences or a related scientific discipline required; advanced degree preferred.
• 10+ years of experience in the biotech or pharmaceutical industry, with a minimum of 7 years in Regulatory Affairs, including significant CMC regulatory experience in clinical-stage and/or commercial biotechnology companies.
• Demonstrated experience leading CMC sections of biologics marketing applications (BLA/MAA) strongly preferred.
• Experience in rare disease drug development preferred.
• Strong working knowledge of FDA regulations, ICH guidelines, and global CMC regulatory requirements.
• Experience with EU and…