Associate Director, Regulatory CMC

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

• 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 Authority requests with authoring support from Manufacturing and Quality team members, including amendments to clinical and commercial manufacturing changes
• Coordinate and manage global submissions, maintain product compliance, and manage change control related activities
• Leverage both technical and regulatory knowledge to proactively mitigate risks
• Serve as the Regulatory Affairs CMC representative in functional and team meetings
• Act as point of contact to cross-functional teams on global Regulatory CMC project/program issues
• Execute regulatory policies and operational processes to deliver high quality regulatory submissions