Director, Regulatory CMC

Director, Regulatory CMCWaltham, MACompany Overview: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.Role Summary: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.Primary Responsibilities Include:Strategic Leadership & Program OwnershipLead and execute global CMC regulatory strategies for assigned programs across all phases of development, including IND, IMPD, BLA/MAA, and post-approval lifecycle managementServe as the CMC regulatory strategist and program leader, proactively identifying regulatory risks, opportunities, and mitigation strategies in alignment with development and commercialization objectivesProvide strategic regulatory guidance to Manufacturing and Quality organizations to ensure global compliance and readiness for clinical and commercial supplyRegulatory Submissions & Health Authority EngagementOversee 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 changesEnsure alignment of CMC regulatory content with evolving regulatory expectations, guidance, and policy trends across regionsCoordinate and manage global regulatory submissions, maintenance of product registrations, and change control activities throughout the product lifecycleCross-Functional Leadership & InfluenceAct as the primary CMC Regulatory Affairs point of contact for cross-functional teams, providing clear direction on global regulatory requirements, timelines, and risksRepresent Regulatory CMC in program, functional, and governance meetings, influencing decision-making without direct authorityPartner closely with Manufacturing, Quality, Clinical Operations, and Program Management to deliver critical regulatory milestonesOperational Excellence & Knowledge LeadershipDrive execution of regulatory policies, processes, and best practices to ensure consistent, compliant, and efficient regulatory operationsLeverage deep technical and regulatory expertise to anticipate challenges and enable proactive problem-solvingMentor and support the development of regulatory team members, fostering a culture of collaboration, accountability, and continuous learningContribute to the advancement of Dyne's regulatory capabilities by sharing knowledge, lessons learned, and regulatory insights across the organizationEducation and Skills Requirements:Bachelor's degree in life sciences or a related scientific discipline required; advanced degree preferred10+ 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 companiesDemonstrated experience leading CMC sections of biologics marketing applications (BLA/MAA) strongly preferredExperience in rare disease drug development preferredStrong working knowledge of FDA regulations, ICH guidelines, and global CMC regulatory requirementsExperience with EU and international regulatory frameworks related to clinical and commercial development is a plusDeep understanding of the drug development process, accelerated regulatory pathways, and evolving global regulatory policy trendsExtensive experience with CTD structure, content, and global submission requirementsProven ability to independently manage multiple complex programs in a fast-paced, dynamic environmentStrong strategic thinking skills with the ability to balance scientific, regulatory, and business considerationsExceptional written and verbal communication skills, including regulatory writing and executive-level communicationDemonstrated ability to influence cross-functional stakeholders and senior leaders without direct authorityHighly collaborative leader and team player with a strong cross-functional mindsetMeticulous attention to detail with a commitment to quality and compliancePositive, proactive, and resilient leader who embodies Dyne's Core ValuesPassion for Dyne's mission and excitement about contributing to the advancement of therapies for patients with serious diseasesAbility to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and prioritiesEmbrace Dyne's core values and cultureMA Pay Range$196,000 - $240,000 USDThe pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.