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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 organizational capability to support long-term growth and sustained high performance 
• Exercise judgment in contributing to corporate strategy, addressing complex and intangible organizational challenges related to regulatory science and policy  
• Interact internally and externally with executive stakeholders across the organization, negotiating and influencing critical matters that affect the entire enterprise 
• Contribute to strategic direction for the regulatory function and influences enterprise-wide initiatives, building trust through transparent communication, empowerment, and inclusion while modeling high standards of leadership across the company 
• Leverage deep company knowledge to foster innovation, guide functional managers and leaders in embedding purpose, accountability, and emotional intelligence into operations, and model Dyne's values through leading with commitment and resolve 
• Exercise judgment in setting and contributing to program and functional strategy, establishes mid-term goals, sets priorities, and ensures execution aligns with corporate objectives and financial performance targets 
• Monitor global regulatory trends and provide strategic guidance to senior leadership  
• Embed Dyne's values into long-term people strategies, and ensure accountability, talent development, and organization-wide alignment  
• Encompass broad decision-making latitude in addressing complex organizational challenges, anticipating regulatory risks and opportunities, and making decisions that influence department-wide direction and enterprise strategy 
• Lead regulatory inspections and audits and ensure corrective actions are implemented promptly 
• Develop and mentor the regulatory affairs team on best practices and regulatory changes  
• Collaborate cross-functionally for successful product development and launch  

Education and Skills Requirements: 

• A Bachelor's degree in life sciences or related discipline is required, with a Master's degree preferred  
• 18+ years of progressive experience in regulatory affairs with a minimum of 10 years in management or leadership roles  
• Deep expertise in regulatory strategy for clinical-stage biotechnology companies is essential, with strong experience in CTD format and content for regulatory filings 
• Demonstrated knowledge of FDA, EMA, and international regulations related to clinical, nonclinical, and CMC development is critical 
• Deep industry knowledge 
• Ability to apply strategic thinking to foster innovation 
• Models Dyne's values of purpose, commitment, vision, and resolve 
• Experience leading health authority meetings, negotiating with regulatory agencies, and influencing enterprise-wide regulatory decisions  
• Outstanding communication skills including regulatory writing, cross-functional collaboration, and the ability to effectively communicate regulatory strategy, risks, and mitigation plans to executive leadership are essential 

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