Executive Director, Regulatory Affairs

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

#LI-Onsite

MA Pay Range

$294,000—$318,000 USD