Associate Director, Regulatory CMC

Benefits

Parental leave

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Non-birth-parent leave

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Family-building benefits

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

Mental health support

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Relocation assistance

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Childcare support

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Learning budget

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Verification

Not verified checked Jun 7, 2026

Salary

$159K-$195K From the posting source

401(k) match

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

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Role

Seniority

Staff Plus From the posting source

Schedule

Shift type

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Weekend work

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Company

Equity

Offered Verified - SEC 10-K source

Application

Cover letter

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Assessment

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Deadline

Not stated

Where they hire

State eligibility is not yet verified.

About this role

Associate 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 Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval. This position supports Dyne's clinical registration, commercial development, and manufacturing efforts, as applicable. This position partners with the manufacturing team, clinical operations, quality, other regulatory team members, and program teams. This role is based in Waltham, MA Primary Responsibilities Include: Lead CMC Regulatory execution for specific programs at all stages of development Provide strategic Regulatory input to the Manufacturing and Quality organizations pertaining to global product development requirements Serve as a CMC strategist and project leader for projects, providing regulatory assessments and developing regulatory strategies with input and guidance from the team and leadership Lead the development of CMC documentation pertaining to global Regulatory filings (IND, IMPD, BLA, etc.) and responses to Health

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