Executive Director, Regulatory Affairs

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 preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. 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   

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   

I nteract 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  

L everag e  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  

E xercise   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   

E mbed   Dyne's values into long-term people strategies, and ensure accountability, talent development, and organization-wide alignment   

E ncompass 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 Skill s  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  

D eep industry knowledge  

Ability to  appl y  strategic thinking to foster innovation  

M odels 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

$270,000 — $310,000 USD

 

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.