Director, Regulatory CMC
Dyne Therapeutics
June 27, 2026
Remote friendly (Waltham, MA)
United States
Corporate Functions
Role Summary
The Director, Regulatory Affairs – Chemistry, Manufacturing, and Controls (CMC) defines and executes global CMC regulatory strategies for Dyne programs across all stages of development through and beyond product approval.
Primary Responsibilities
- Lead and execute global CMC regulatory strategies (IND, IMPD, BLA/MAA, and post-approval lifecycle management).
- Identify regulatory risks/opportunities and develop mitigation aligned to development and commercialization goals.
- Provide strategic CMC regulatory guidance to Manufacturing and Quality to ensure global compliance and clinical/commercial readiness.
- Oversee planning, development, and delivery of high-quality CMC sections and responses to Health Authority questions, including manufacturing changes.
- Ensure CMC regulatory content aligns with evolving regional expectations, guidance, and policy trends.
- Coordinate/manage global regulatory submissions, product registration maintenance, and change control activities.
- Serve as primary CMC Regulatory Affairs point of contact; provide direction on requirements, timelines, and risks.
- Represent Regulatory CMC in meetings and influence decisions without direct authority.
- Partner with Manufacturing, Quality, Clinical Operations, and Program Management on regulatory milestones.
- Drive regulatory policies/processes/best practices; anticipate challenges and enable proactive problem-solving.
- Mentor regulatory team members and share knowledge/insights across the organization.
Education & Skills Requirements
- Bachelor’s degree in life sciences (advanced degree preferred).
- 10+ years in biotech/pharma; 7+ years in Regulatory Affairs with significant CMC experience in clinical-stage and/or commercial biotech.
- Strongly preferred: experience leading CMC sections of biologics BLA/MAA.
- Preferred: rare disease drug development experience.
- Strong knowledge of FDA regulations, ICH guidelines, and global CMC requirements.
- Plus: EU/international frameworks.
- Deep understanding of drug development, accelerated pathways, CTD structure/content, and global submissions.
- Ability to independently manage multiple complex programs; strong strategic thinking.
- Exceptional written/verbal regulatory and executive communication.
- Ability to influence cross-functional stakeholders without direct authority; collaborative; detail-oriented; quality/compliance focused.
- Ability to meet deadlines and adapt quickly.
Compensation
- MA pay range: $196,000–$240,000 USD.
The Director, Regulatory Affairs – Chemistry, Manufacturing, and Controls (CMC) defines and executes global CMC regulatory strategies for Dyne programs across all stages of development through and beyond product approval.
Primary Responsibilities
- Lead and execute global CMC regulatory strategies (IND, IMPD, BLA/MAA, and post-approval lifecycle management).
- Identify regulatory risks/opportunities and develop mitigation aligned to development and commercialization goals.
- Provide strategic CMC regulatory guidance to Manufacturing and Quality to ensure global compliance and clinical/commercial readiness.
- Oversee planning, development, and delivery of high-quality CMC sections and responses to Health Authority questions, including manufacturing changes.
- Ensure CMC regulatory content aligns with evolving regional expectations, guidance, and policy trends.
- Coordinate/manage global regulatory submissions, product registration maintenance, and change control activities.
- Serve as primary CMC Regulatory Affairs point of contact; provide direction on requirements, timelines, and risks.
- Represent Regulatory CMC in meetings and influence decisions without direct authority.
- Partner with Manufacturing, Quality, Clinical Operations, and Program Management on regulatory milestones.
- Drive regulatory policies/processes/best practices; anticipate challenges and enable proactive problem-solving.
- Mentor regulatory team members and share knowledge/insights across the organization.
Education & Skills Requirements
- Bachelor’s degree in life sciences (advanced degree preferred).
- 10+ years in biotech/pharma; 7+ years in Regulatory Affairs with significant CMC experience in clinical-stage and/or commercial biotech.
- Strongly preferred: experience leading CMC sections of biologics BLA/MAA.
- Preferred: rare disease drug development experience.
- Strong knowledge of FDA regulations, ICH guidelines, and global CMC requirements.
- Plus: EU/international frameworks.
- Deep understanding of drug development, accelerated pathways, CTD structure/content, and global submissions.
- Ability to independently manage multiple complex programs; strong strategic thinking.
- Exceptional written/verbal regulatory and executive communication.
- Ability to influence cross-functional stakeholders without direct authority; collaborative; detail-oriented; quality/compliance focused.
- Ability to meet deadlines and adapt quickly.
Compensation
- MA pay range: $196,000–$240,000 USD.