Associate Director, Regulatory CMC

Company 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 pre‑clinical 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 and follow us on X, LinkedIn and Facebook. Role Summary The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late‑stage development through and beyond approval. This position supports Dyne’s clinical registration, commercial development, and manufacturing efforts, as applicable. This role partners with the manufacturing team, clinical operations, quality, other regulatory team members, and program teams. Location: Waltham, MA. Primary Responsibilities Lead CMC regulatory execution for specific programs at all stages of development. Provide strategic regulatory input to the manufacturing and quality organizations pertaining to global product development requirements. Serve as a CMC strategist and project leader for projects, providing regulatory assessments and developing regulatory strategies with input and guidance from the team and leadership. Lead the development of CMC documentation pertaining to global regulatory filings (IND, IMPD, BLA, etc.) and responses to Health Authority requests with authoring support from manufacturing and quality team members, including amendments to clinical and commercial manufacturing changes. Coordinate and manage global submissions, maintain product compliance, and manage change control related activities. Leverage both technical and regulatory knowledge to proactively mitigate risks. Act as the Regulatory Affairs CMC representative in functional and team meetings. Serve as the point of contact to cross‑functional teams on global regulatory CMC project/program issues. Execute regulatory policies and operational processes to deliver high quality regulatory submissions. Education and Skills Requirements Minimum of a bachelor’s degree in life science or related discipline. Minimum of 7 years of experience in the biotech/pharmaceutical industry, and a minimum of 5 years in regulatory affairs in a clinical‑stage and/or commercial biotechnology company. Experience in Rare Disease preferred. Experience leading and developing CMC sections of biologics marketing applications preferred. Solid understanding of FDA regulatory guidance, ICH guidelines. Strong experience with CTD format and content of regulatory filings. Thorough understanding of drug development process and the pharmaceutical industry including global regulatory CMC requirements, guidance, accelerated regulatory review paths, and policy trends. Knowledge of EU and international regulations related to clinical and nonclinical development a plus. Ability to work independently to manage multiple projects in a fast‑paced environment. Ability to effectively collaborate in a dynamic, cross‑functional environment to meet each program’s critical regulatory milestones. Ability to effectively communicate the regulatory strategy, risks, mitigations, and overall plans to project/program teams and senior management. Outstanding communication skills (verbal and written), regulatory‑writing skills and willingness to share knowledge and lessons learned with strong attention to detail. Recognized as a leader, team player, and possess a cross‑functional collaborative skill set. Ability to influence without authority. Positive team member who embodies the Dyne Core Values. Excitement about Dyne’s vision and mission. Pay Range $159,000 - $195,000 USD. 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. #J-18808-Ljbffr