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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 Executive Director, Regulatory Affairs serves as a visionary leader who shapes long-term program regulatory strategy, collaborates on regulatory functional strategy, and drives organizational impact across Dyne's regulatory operations. The Executive Director provides strategic program direction for regulatory affairs, ensuring compliance with applicable regulations and maintaining strong relationships with regulatory bodies. This position requires a leader who contributes to department-wide strategy, develops corporate policies and processes that influence the organization's direction, and ensures alignment with the mission of delivering meaningful outcomes for patients. The role demands strategic program regulatory oversight and execution of regulatory strategies that align with business objectives and support the achievement of timely regulatory interactions and filings. This role requires a leader with emotionally intelligent leadership, embedding Dyne's values into long-term people strategies while ensuring accountability, talent development, and organization-wide alignment.    This role is based in Waltham, MA.    Primary Responsibilities  Include :   Shape and lead comprehensive global regulatory strategy for  a Dyne program , driving long-term vision that aligns with corporate , functional, and program  objectives  and advances patient-focused mission   Contribute to  functional  strategy by  collaborating to  establish  mid-term goals, setting strategic priorities, and ensuring execution aligns with financial performance targets and organizational objectives   Provide strategic oversight of regulatory function  for a program  through functional managers and leaders, setting the tone for emotionally intelligent, feedback-driven leadership across the organization   Partner with executive stakeholders to negotiate and influence critical regulatory matters affecting the entire organization, building trust through transparent communication and inclusion   Develop and  execute  corporate regulatory policies that influence organizational direction, ensuring alignment with delivering meaningful outcomes for patients    Lead interactions with global health authorities including FDA, EMA, and other regulatory agencies,  representing  the company at critical strategic meetings and shaping regulatory pathway decisions   Ensure compliance with regulatory requirements throughout the product  lifecycle    Oversee preparation and submission of major regulatory filings including INDs, CTAs, NDAs, BLAs, and MAAs,  maintaining  compliance with all regulatory requirements   Direct regulatory  program  strategy for expedited programs and designations for rare muscle diseases, including Fast Track, Orphan Drug Designation, Breakthrough Therapy, and Regenerative Medicine Advanced Therapy designations  &nbsp