Executive Director, Regulatory Affairs

About this role

<div class="content-intro"><h3>Company Overview:</h3> <p>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 <a href="https://www.dyne-tx.com/">https://www.dyne-tx.com/</a>, and follow us on <a href="https://x.com/dyne_tx">X</a>, <a href="https://www.linkedin.com/company/dynetx/">LinkedIn</a> and <a href="https://www.facebook.com/DyneTherapeutic/">Facebook</a>.</p></div><p><strong>Role Summary:</strong></p> <p data-ccp-border-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-contrast="none">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. </span><span data-ccp-props="{}"> </span></p> <p data-ccp-border-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-contrast="none">This role is based in Waltham, MA. </span><span data-ccp-props="{}"> </span></p> <p data-ccp-border-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><strong><span data-contrast="none"><span data-ccp-parastyle="Body">Primary Responsibilities</span><span data-ccp-parastyle="Body"> Include</span><span data-ccp-parastyle="Body">:</span></span></strong><span data-ccp-props="{"335559739":120}"> </span></p> <ul> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Shape and lead comprehensive global regulatory strategy for</span><span data-ccp-parastyle="Body"> a Dyne program</span><span data-ccp-parastyle="Body">, driving long-term vision that aligns with corporate</span><span data-ccp-parastyle="Body">, functional, and program </span><span data-ccp-parastyle="Body">objectives</span><span data-ccp-parastyle="Body"> and advances patient-focused mission</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Contribute to </span><span data-ccp-parastyle="Body">functional</span><span data-ccp-parastyle="Body"> strategy by </span><span data-ccp-parastyle="Body">collaborating to </span><span data-ccp-parastyle="Body">establish</span><span data-ccp-parastyle="Body"> mid-term goals, setting strategic priorities, and ensuring execution aligns with financial performance targets and organizational objectives</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span data-contrast="none"><span data-ccp-parastyle="Body">Provide strategic oversight of regulatory function</span><span data-ccp-parastyle="Body"> for a program</span><span data-ccp-parastyle="Body"> through functional managers and leaders, setting the tone for emotionally intelligent, feedback-driven leadership across the organization</span></span><span data-ccp-props="{"335559739":120}"> </span></li> <li><span…