Director, Regulatory CMC

Role Summary:

The Director, Regulatory Affairs – Chemistry, Manufacturing, and Controls (CMC) is responsible for defining and executing global CMC regulatory strategies for Dyne programs across all stages of development, through and beyond product approval. This role plays a critical leadership role in enabling clinical registration, commercial readiness, and manufacturing lifecycle management by ensuring high-quality, compliant, and strategically aligned CMC regulatory submissions worldwide. 

The Director serves as a key strategic partner to Manufacturing, Quality, Clinical Operations, Program Teams, and the broader Regulatory organization, providing expert regulatory guidance, risk assessment, and leadership across early- and late-stage programs. This role operates with a high degree of independence and influence, contributing to program-level decision-making and organizational regulatory excellence. 

This role is based in Waltham, MA. 

Primary Responsibilities Include:

Strategic Leadership & Program Ownership 

• Lead and execute global CMC regulatory strategies for assigned programs across all phases of development, including IND, IMPD, BLA/MAA, and post-approval lifecycle management 
• Serve as the CMC regulatory strategist and program leader, proactively identifying regulatory risks, opportunities, and mitigation strategies in alignment with development and commercialization objectives 
• Provide strategic regulatory guidance to Manufacturing and Quality organizations to ensure global compliance and readiness for clinical and commercial supply 

Regulatory Submissions & Health Authority Engagement 

• Oversee the planning, development, and delivery of high-quality CMC sections for global regulatory submissions and responses to Health Authority questions, including clinical and commercial manufacturing changes 
• Ensure alignment of CMC regulatory content with evolving regulatory expectations, guidance, and policy trends across regions 
• Coordinate and manage global regulatory submissions, maintenance of product registrations, and change control activities throughout the product lifecycle 

Cross-Functional Leadership & Influence 

• Act as the primary CMC Regulatory Affairs point of contact for cross-functional teams, providing clear direction on global regulatory requirements, timelines, and risks 
• Represent Regulatory CMC in program, functional, and governance meetings, influencing decision-making without direct authority 
• Partner closely with Manufacturing, Quality, Clinical Operations, and Program Management to deliver critical regulatory milestones 

Operational Excellence & Knowledge Leadership 

• Drive execution of regulatory policies, processes, and best practices to ensure consistent, compliant, and efficient regulatory operations 
• Leverage deep technical and regulatory expertise to anticipate challenges and enable proactive problem-solving 
• Mentor and support the development of regulatory team members, fostering a culture of collaboration, accountability, and continuous learning 
• Contribute to the advancement of Dyne’s regulatory capabilities by sharing knowledge, lessons learned, and regulatory insights across the organization 

Education and Skills Requirements:

• Bachelor’s degree in life sciences or a related scientific discipline required; advanced degree preferred 
• 10+ years of experience in the biotech or pharmaceutical industry, with a minimum of 7 years in Regulatory Affairs, including significant CMC regulatory experience in clinical-stage and/or commercial biotechnology companies 
• Demonstrated experience leading CMC sections of biologics marketing applications (BLA/MAA) strongly preferred 
• Experience in rare disease drug development preferred 
• Strong working knowledge of FDA regulations, ICH guidelines, and global CMC regulatory requirements 
• Experience with EU and international regulatory frameworks related to clinical and commercial development is a plus 
• Deep understanding of the drug development process, accelerated regulatory pathways, and evolving global regulatory policy trends 
• Extensive experience with CTD structure, content, and global submission requirements 
• Proven ability to independently manage multiple complex programs in a fast-paced, dynamic environment 
• Strong strategic thinking skills with the ability to balance scientific, regulatory, and business considerations 
• Exceptional written and verbal communication skills, including regulatory writing and executive-level communication 
• Demonstrated ability to influence cross-functional stakeholders and senior leaders without direct authority 
• Highly collaborative leader and team player with a strong cross-functional mindset 
• Meticulous attention to detail with a commitment to quality and compliance 
• Positive, proactive, and resilient leader who embodies Dyne’s Core Values  
• Passion for Dyne’s mission and excitement about contributing to the advancement of therapies for patients with serious diseases 
• Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities 
• Embrace Dyne’s core values and culture 

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