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Dyne Therapeutics is seeking an Associate Director of Regulatory Chemistry Manufacturing and Control (CMC) to lead CMC regulatory strategies for their neuromuscular disease therapeutics. This role involves collaboration with various teams to ensure compliance and successful product development throughout clinical and commercial phases.
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Job Summary
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases.
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.
Matching Summary
Match Score: 75
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Dyne Therapeutics is seeking an Associate Director of Regulatory Chemistry Manufacturing and Control (CMC) to lead CMC regulatory strategies for their neuromuscular disease therapeutics. This role involves collaboration with various teams to ensure compliance and successful product development throughout clinical and commercial phases.
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Skills & Requirements
Must-have
Execute global CMC regulatory strategies
Lead CMC regulatory documentation
Manage global submissions and compliance
Provide regulatory input to manufacturing
Nice-to-have
Deliver functional improvement for patients
Advance clinical and preclinical programs
Partner with cross-functional teams
Key Requirements
Associate Director level experience
Experience with global regulatory filings (IND, IMPD, BLA)