---
title: 'Executive Director, Regulatory Affairs at Dyne Therapeutics'
canonical: 'https://feeny.ai/job/executive-director-regulatory-affairs-dyne-therapeutics-waltham-06bah5qbsvbr'
type: 'job'
last_seen: '2026-11-02'
---

# Executive Director, Regulatory Affairs at Dyne Therapeutics

- **Company:** Dyne Therapeutics
- **Location:** Waltham, MA
- **Compensation:** $294k–$318k
- **Posted:** 2026-05-27
- **Last confirmed live:** 2026-11-02
- **Apply:** https://job-boards.greenhouse.io/dynetherapeutics/jobs/6001521004

## 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/](https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0), and follow us on [X](https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0), [LinkedIn](https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0) and [Facebook](https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0).

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

#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.

## About Dyne Therapeutics

## Company Overview
- **One-liner**: Dyne Therapeutics is a clinical-stage biotechnology company developing targeted nucleic acid therapies for genetically driven neuromuscular diseases using its proprietary FORCE™ platform.
- **Entity Type**: Public (NASDAQ: DYN)
- **Headquarters**: Waltham, Massachusetts, United States
- **Founded**: 2018
- **Founders**: Not publicly available (the company was co-founded by a team of scientists and entrepreneurs; individual names not surfaced in search results)

## Core Business
- **Primary industry**: Biotechnology / Biopharmaceuticals – rare neuromuscular disease therapeutics
- **Target customers**: B2B / B2G – regulatory agencies, healthcare providers, payers, and most importantly patients with Duchenne muscular dystrophy (DMD), myotonic dystrophy type 1 (DM1), facioscapulohumeral muscular dystrophy (FSHD), and Pompe disease.
- **Mission / Purpose**: “Delivering functional improvement for people living with neuromuscular diseases.” [dyne-tx.com](https://www.dyne-tx.com/)

## Products & Services
Dyne’s pipeline is built around its FORCE™ platform, which uses an antigen-binding fragment (Fab) conjugated to transferrin receptor 1 (TfR1) to deliver therapeutic payloads to muscle and the central nervous system.

- **Z‑rostudirsen (DYNE‑251)** – An investigational therapeutic for DMD patients amenable to exon 51 skipping. Consists of a phosphorodiamidate morpholino oligomer (PMO) conjugated to an anti‑TfR1 Fab. Phase 1/2 DELIVER trial met primary endpoint; BLA submission for U.S. Accelerated Approval planned for Q2 2026 with potential launch in Q1 2027. [investors.dyne-tx.com](https://investors.dyne-tx.com/news-releases/news-release-details/dyne-therapeutics-reports-fourth-quarter-and-full-year-2025)
- **Z‑basivarsen (DYNE‑101)** – Investigational therapeutic for DM1, using an antisense oligonucleotide (ASO) conjugated to anti‑TfR1 Fab. Phase 1/2 ACHIEVE trial fully enrolled; Phase 3 HARMONIA trial ongoing. [dyne-tx.com](https://www.dyne-tx.com/pipeline/)
- **DYNE‑302** – Preclinical candidate for FSHD, using an siRNA payload to suppress DUX4 expression. [dyne-tx.com](https://www.dyne-tx.com/pipeline/)
- **DMD Franchise Expansion** – Four additional development candidates (DYNE‑253, DYNE‑245, DYNE‑244, DYNE‑255) targeting exons 53, 45, 44, and 55 for DMD, entering IND‑enabling studies. [investors.dyne-tx.com](https://investors.dyne-tx.com/news-releases/news-release-details/dyne-therapeutics-reports-fourth-quarter-and-full-year-2025)

## Market Standing
- **Valuation / Market Cap**: Not disclosed in search results (public company; market cap fluctuates with stock price; current figure not provided in the sources).
- **Key Metric**: Cash, cash equivalents and marketable securities of **$1.1 billion** as of December 31, 2025, providing runway into Q1 2028. [investors.dyne-tx.com](https://investors.dyne-tx.com/news-releases/news-release-details/dyne-therapeutics-reports-fourth-quarter-and-full-year-2025)
- **Notable Investors / Partners**: Not listed in provided search results (likely institutional investors; prior venture rounds not detailed here).
- **Growth Signals**:
  - Headcount grew **38.2% YoY** to **227 employees** (2025). [linkedin.com](https://www.linkedin.com/company/dynetx)
  - Positive topline results from DELIVER trial for z‑rostudirsen; potential first product launch in Q1 2027 if approved.
  - Advancing five distinct clinical/preclinical programs across multiple neuromuscular indications.

## Competitive Advantages
- **FORCE™ Platform**: Differentiated delivery technology that uses a TfR1‑binding Fab to enable broad and deep tissue penetration in both muscle and CNS – addressing one of the biggest hurdles in neuromuscular drug development.
- **Best‑in‑Class Potential**: Clinical data for z‑rostudirsen showed statistically significant dystrophin expression (5.46% of normal at 6 months, 7‑fold change) and preservation of lung function (FVC%p) compared to placebo, despite a small trial not powered for functional endpoints.
- **Broad Pipeline**: Covering multiple exon‑skipping opportunities in DMD as well as entirely different diseases (DM1, FSHD, Pompe) with the same core platform, reducing risk and enabling rapid expansion.

## Strategic Focus
- **Regulatory Submission**: File a Biologics License Application (BLA) for z‑rostudirsen in Q2 2026 under U.S. Accelerated Approval pathway.
- **Late‑Stage Trials**: Initiate two field‑defining Phase 3 confirmatory trials (FORZETTO for DMD and HARMONIA for DM1) in 2026 following FDA alignment on design.
- **Pipeline Expansion**: Move four additional DMD exon‑skipping candidates into IND‑enabling studies and advance preclinical DYNE‑302 (FSHD) toward the clinic.
- **Commercial Readiness**: Prepare for potential first‑ever company launch in Q1 2027 with a focus on U.S. market, while also pursuing ex‑U.S. approval pathways.

## Why Work Here
- **Mission‑Driven Culture**: The company’s “One Dyne community” ethos emphasizes accountability, transparency, fearlessness, and a relentless drive to deliver functional improvement for patients and families. [dyne-tx.com](https://www.dyne-tx.com/careers-culture/)
- **Competitive Benefits**: Medical, dental, vision, 401(k), flexible vacation, paid holidays including a year‑end office closure, short‑ & long‑term disability, HSA/FSA accounts. [dyne-tx.com](https://www.dyne-tx.com/careers-culture/)
- **Work Environment**: Office location in Waltham, MA (Boston area). Remote/hybrid policy not specified in search results; likely on‑site or hybrid for lab‑based roles. Career page lists roles such as Associate Director, Oligonucleotide Development; Scientist, RNA; Director of Training – reflecting a mix of research, clinical, and corporate functions. [job-boards.greenhouse.io](https://job-boards.greenhouse.io/dynetherapeutics)
- **Growth Opportunity**: Joining a late‑stage biotech with a validated platform, strong cash position, and a clear path to commercialization – offering employees exposure to both R&D and upcoming launch activities.
- **Recruitment Scam Warning**: Dyne posts an explicit notice on its careers page that it never requests financial details or payment during hiring; all legitimate emails come from @dyne‑tx.com addresses.

## Sources
1. [dyne-tx.com – Company Overview](https://www.dyne-tx.com/)
2. [dyne-tx.com – Careers & Culture](https://www.dyne-tx.com/careers-culture/)
3. [dyne-tx.com – Pipeline](https://www.dyne-tx.com/pipeline/)
4. [investors.dyne-tx.com – Q4/Full Year 2025 Results](https://investors.dyne-tx.com/news-releases/news-release-details/dyne-therapeutics-reports-fourth-quarter-and-full-year-2025)
5. [linkedin.com – Dyne Therapeutics Company Profile](https://www.linkedin.com/company/dynetx)
6. [job-boards.greenhouse.io – Dyne Careers Page](https://job-boards.greenhouse.io/dynetherapeutics)

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