Director, Regulatory CMC

Benefits

Parental leave

Not verified

Non-birth-parent leave

Not verified

Family-building benefits

• Fertility benefits: Not verified
• Adoption assistance: Not verified
• Surrogacy assistance: Not verified

Mental health support

Not verified

Relocation assistance

Not verified

Childcare support

Not verified

Learning budget

Not verified

Verification

Not verified checked Jun 7, 2026

Salary

$196K-$240K From the posting source

401(k) match

Reported from DOL Form 5500 industry filing (not employer-specific)

Was this benefit information wrong? Tell us.

Role

Seniority

Staff Plus From the posting source

Schedule

Shift type

Not verified

Weekend work

Not verified

Company

Equity

Offered Verified - SEC 10-K source

Application

Cover letter

Not verified

Assessment

Not verified

Deadline

Not stated

Where they hire

State eligibility is not yet verified.

About this role

Director, Regulatory CMC Waltham, MA 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 a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. 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 Director, Regulatory Affairs - Chemistry, Manufacturing, and Controls (CMC) is responsible for defining and executing global CMC regulatory strategies for Dyne programs across all stages of development, through and beyond product approval. This role plays a critical leadership role in enabling clinical registration, commercial readiness, and manufacturing lifecycle management by ensuring high-quality, compliant, and strategically aligned CMC regulatory submissions worldwide. The Director serves as a key strategic partner to Manufacturing, Quality, Clinical Operations, Program Teams, and the broader Regulatory organization, providing expert regulatory guidance, risk assessment, and leadership across early- and late-stage programs. This role operates with a high degree of independence and influence, contributing to program-level decision-making and organizational regulatory excellence. This role is based in Waltham, MA. Primary Responsibilities Include: Strategic Leadership & Program Ownership Lead and execute global CMC regulatory strategies for assigned programs across all phases of development,

Read the full description at job-boards.greenhouse.io. FewerJobs shows a preview and links to the original posting.