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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 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 . 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 position partners with the manufacturing team, clinical operations, quality, other regulatory team members, and program teams.    This role is based in Waltham, MA  Primary Responsibilities Include: 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   Responsible for the coordination and management of global submissions, maintenance of product compliance, and management of change control related activities   Leverage both technical and regulatory knowledge to proactively mitigate risks   Serves as the Regulatory Affairs CMC representative in functional and team meetings   Act as 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 is required   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