Associate Director, Regulatory CMC

Dyne Therapeutics(1 month ago)

Waltham, MAOnsiteFull TimeDirector$209,480 - $278,758 (estimated)Regulatory Affairs

About this role

The Associate Director, Regulatory CMC is responsible for executing global CMC regulatory strategies across early and late-stage development to support clinical registration, commercial development, and manufacturing efforts. The role partners closely with manufacturing, quality, clinical operations, regulatory colleagues, and program teams to advance programs toward approval. The position is based in Waltham, MA and acts as Dyne’s CMC regulatory representative across functional meetings and cross-functional programs.

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Required Skills

CMC Regulatory
Regulatory Strategy
Manufacturing Liaison
Quality Liaison
Project Leadership
Regulatory Writing
Global Submissions
Change Control
Risk Mitigation
Cross-Functional

+4 more

Qualifications

Bachelor's Degree in Life Science or Related Discipline

About Dyne Therapeutics

dyne-tx.com

Dyne Therapeutics is a biotechnology company developing nucleic acid–based therapies for rare, inherited muscle diseases. With the mission "Repairing muscle, reclaiming now," it aims to create life‑transforming medicines that restore muscle function and improve patients' lives. Dyne advances programs from discovery into clinical development with a focus on genetic muscle disorders (including various muscular dystrophies) and works with partners to accelerate delivery of therapies to patients.