Director, Regulatory CMC

Dyne Therapeutics•Waltham, MA

15h•$196,000 - $240,000•Onsite

About The Position

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing 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) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook. The Director, Regulatory Affairs – Chemistry, Manufacturing, and Controls (CMC) is responsible for defining and executing 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 serves as 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. This 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.

Requirements

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
Strong working knowledge of FDA regulations, ICH guidelines, and global CMC regulatory requirements
Extensive experience with CTD structure, content, and global submission requirements
Proven ability to independently manage multiple complex programs in a fast-paced, dynamic environment
Strong strategic thinking skills with the ability to balance scientific, regulatory, and business considerations
Exceptional written and verbal communication skills, including regulatory writing and executive-level communication
Demonstrated ability to influence cross-functional stakeholders and senior leaders without direct authority
Highly collaborative leader and team player with a strong cross-functional mindset
Meticulous attention to detail with a commitment to quality and compliance
Positive, proactive, and resilient leader who embodies Dyne’s Core Values
Passion for Dyne’s mission and excitement about contributing to the advancement of therapies for patients with serious diseases
Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities
Embrace Dyne’s core values and culture

Nice To Haves

Demonstrated experience leading CMC sections of biologics marketing applications (BLA/MAA) strongly preferred
Experience in rare disease drug development preferred
Experience with EU and international regulatory frameworks related to clinical and commercial development is a plus

Responsibilities

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