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 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 https://x.com/dyne_tx, https://www.linkedin.com/company/dynetx/ and https://www.facebook.com/DyneTherapeutic/. 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  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   #LI-Onsite MA Pay Range$159,000—$195,000 USD   The 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. Offices: Waltham, Massachusetts, United States (Waltham, MA);