Associate Director, Regulatory CMC

The Associate Director, Regulatory CMC is accountable for executing global CMC regulatory strategies for programs in early and late-stage development through and beyond approval. This position supports Dyne's clinical registration, commercial development, and manufacturing efforts.

Requirements

• 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