Executive Director, Regulatory Affairs

Regulatory Jobs; Waltham (MA); On-site; USD 294,000 - 318,000; Full time

Job summary

Dyne Therapeutics seeks an Executive Director of Regulatory Affairs to shape long-term regulatory strategy and provide strategic direction across regulatory operations in support of patient-centered programs.

The role requires deep expertise with FDA/EMA regulations, CTD filings, and a proven track record in leading regulatory teams through complex interactions and filings. Based in Waltham, MA, this position emphasizes leadership, collaboration, and delivering timely regulatory outcomes.

Qualifications

• Bachelor's degree in life sciences or related field required, Master's preferred.
• 18+ years in regulatory affairs with at least 10 years in management.
• Deep expertise in regulatory strategy for clinical-stage biotech, CTD format and filings.
• Strong knowledge of FDA/EMA and international regulations.

Responsibilities

• Shape and lead global regulatory strategy for Dyne programs.
• Collaborate to set mid-term goals and ensure execution with financial targets.
• Provide strategic oversight of regulatory functions through leaders.
• Negotiate with health authorities and influence enterprise decisions.
• Develop corporate regulatory policies aligning with patient outcomes.
• Lead interactions with FDA, EMA and other agencies.
• Oversee major filings (INDs, CTAs, NDAs, BLAs, MAAs) and lifecycle compliance.
• Mentor regulatory professionals and build organizational capability.
• Embed Dyne values and emotional intelligence into regulatory operations.

Skills

Regulatory strategy

Leadership

Regulatory writing

Cross-functional collaboration

FDA knowledge

Education

Bachelor's degree in life sciences

Master's degree preferred

Job description

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-termprogramregulatorystrategy,collaborates onregulatoryfunctional strategy,and drives organizational impact across Dyne's regulatory operations.The Executive Director provides strategicprogramdirection for regulatory affairs, ensuring compliance with applicable regulations andmaintainingstrong relationships with regulatory bodies.This position requires a leader who contributes to department-wide strategy, develops corporate policiesand processesthat influence the organization's direction, and ensures alignment with the mission of delivering meaningful outcomes for patients. The role demands strategicprogramregulatoryoversightand execution of regulatory strategies that align with businessobjectivesandsupportthe achievement oftimelyregulatoryinteractions and filings. This role requires a leaderwith emotionally intelligent leadership, embedding Dyne's valuesinto long-termpeoplestrategies while ensuring accountability, talent development, and organization-wide alignment.

This role is based in Waltham, MA.

Primary ResponsibilitiesInclude:

• Shape and lead comprehensive global regulatory strategy fora Dyne program, driving long-term vision that aligns with corporate, functional, and programobjectivesand advances patient-focused mission
• Contribute tofunctionalstrategy bycollaborating toestablishmid-term goals, setting strategic priorities, and ensuring execution aligns with financial performance targets and organizational objectives
• Provide strategic oversight of regulatory functionfor a programthrough 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 andexecutecorporate 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,representingthe company at critical strategic meetings and shaping regulatory pathway decisions
• Ensure compliance with regulatory requirements throughout the productlifecycle
• Oversee preparation and submission of major regulatory filings including INDs, CTAs, NDAs, BLAs, and MAAs,maintainingcompliance with all regulatory requirements
• Direct regulatoryprogramstrategy 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 byleveragingdeep 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 tostrategic direction for the regulatory function andinfluences enterprise-wide initiatives, building trust through transparent communication, empowerment, and inclusion while modelinghigh standardsof leadership across the company
• Leveragedeep 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
• Exercisejudgment insetting and contributingtoprogram and functionalstrategy,establishesmid-term goals, sets priorities, and ensures execution aligns with corporateobjectivesand financial performance targets
• Monitor global regulatory trends andprovidestrategic guidance to senior leadership
• EmbedDyne'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,anticipatingregulatory 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 SkillsRequirements:

• ABachelor'sdegree in life sciences or related discipline isrequired, with aMaster'sdegree preferred
• 18+ years of progressive experience in regulatory affairs with a minimum of 10 years in management or leadership roles
• Deepexpertisein 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 toapplystrategic 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

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.