Executive Director, Regulatory Affairs

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 and follow us onXLinkedInandFacebook.

Role Summary:

The Executive Director Regulatory Affairs serves as a visionary leader who shapes long-termprogramregulatorystrategycollaborates onregulatoryfunctional strategyand drives organizational impact across Dynes regulatory Executive Director provides strategicprogramdirection for regulatory affairs ensuring compliance with applicable regulations andmaintainingstrong relationships with regulatory position requires a leader who contributes to department-wide strategy develops corporate policiesand processesthat influence the organizations 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 Dynes 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 agenciesrepresentingthe 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 MAAsmaintainingcompliance 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 Dynes values through leading with commitment and resolve
• Exercisejudgment insetting and contributingtoprogram and functionalstrategyestablishesmid-term goals sets priorities and ensures execution aligns with corporateobjectivesand financial performance targets
• Monitor global regulatory trends andprovidestrategic guidance to senior leadership
• EmbedDynes values into long-term people strategies and ensure accountability talent development and organization-wide alignment
• Encompass broad decision-making latitude in addressing complex organizational challengesanticipatingregulatory 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:

• ABachelorsdegree in life sciences or related discipline is with aMastersdegree 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 Dynes 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

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.