Associate Director, Regulatory CMC
Dyne Therapeutics
June 27, 2026
Remote friendly (Waltham, MA)
United States
$159,000 - $195,000 USD yearly
Corporate Functions
Role Summary
The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for programs in early and late-stage development through and beyond approval. Partners with manufacturing, clinical operations, quality, regulatory, and program teams. Location: Waltham, MA
Primary Responsibilities
- Lead CMC Regulatory execution for specific programs at all stages of development
- Provide strategic regulatory input to Manufacturing and Quality regarding global product development requirements
- Serve as a CMC strategist and project leader; develop regulatory assessments and strategies
- Lead development of CMC documentation for global regulatory filings (IND, IMPD, BLA, etc.) and responses to Health Authority requests (including amendments to clinical and commercial manufacturing changes)
- Coordinate and manage global submissions, maintain product compliance, and manage change control activities
- Proactively mitigate risks using technical and regulatory knowledge
- Serve as the Regulatory Affairs CMC representative in meetings; point of contact for cross-functional teams
- Execute regulatory policies/operational processes to deliver high-quality submissions
Education & Qualifications
- Bachelor’s degree in life science or related discipline (required)
- 7+ years biotech/pharmaceutical experience; 5+ years regulatory affairs in clinical-stage and/or commercial biotechnology (required)
- Rare Disease experience (preferred)
- Experience leading/developing CMC sections of biologics marketing applications (preferred)
- Solid FDA guidance/ICH understanding; strong CTD filing knowledge
- Understanding of global CMC requirements, accelerated review paths, and policy trends
- EU/international regulations knowledge (plus)
- Independently manage multiple projects; collaborate cross-functionally; communicate strategy/risks to senior teams; strong regulatory writing and attention to detail; influence without authority
Pay Range (MA)
$159,000 - $195,000 USD
The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for programs in early and late-stage development through and beyond approval. Partners with manufacturing, clinical operations, quality, regulatory, and program teams. Location: Waltham, MA
Primary Responsibilities
- Lead CMC Regulatory execution for specific programs at all stages of development
- Provide strategic regulatory input to Manufacturing and Quality regarding global product development requirements
- Serve as a CMC strategist and project leader; develop regulatory assessments and strategies
- Lead development of CMC documentation for global regulatory filings (IND, IMPD, BLA, etc.) and responses to Health Authority requests (including amendments to clinical and commercial manufacturing changes)
- Coordinate and manage global submissions, maintain product compliance, and manage change control activities
- Proactively mitigate risks using technical and regulatory knowledge
- Serve as the Regulatory Affairs CMC representative in meetings; point of contact for cross-functional teams
- Execute regulatory policies/operational processes to deliver high-quality submissions
Education & Qualifications
- Bachelor’s degree in life science or related discipline (required)
- 7+ years biotech/pharmaceutical experience; 5+ years regulatory affairs in clinical-stage and/or commercial biotechnology (required)
- Rare Disease experience (preferred)
- Experience leading/developing CMC sections of biologics marketing applications (preferred)
- Solid FDA guidance/ICH understanding; strong CTD filing knowledge
- Understanding of global CMC requirements, accelerated review paths, and policy trends
- EU/international regulations knowledge (plus)
- Independently manage multiple projects; collaborate cross-functionally; communicate strategy/risks to senior teams; strong regulatory writing and attention to detail; influence without authority
Pay Range (MA)
$159,000 - $195,000 USD