Executive Director, Regulatory Affairs

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  
• Foster innovation and bold thinking across the regulatory team by leveraging deep company knowledge, guiding functional leaders in embedding purpose, accountability, and emotional intelligence into operations 
• Lead talent development initiatives, mentoring senior regulatory professionals and building