Dyne Therapeutics
Director, Regulatory CMC
Waltham, MA · Director
Sponsorship not specifiedDetected 21 days ago
Product ManagementFDA RegulatoryAnimal StudiesLeadershipCommunicationCollaborationProblem SolvingRegulatory Affairs
About the role
- Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases.
- The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.
- Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Responsibilities
- 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
- Coordinate and manage global regulatory submissions, maintenance of product registrations, and change control activities throughout the product lifecycle
- Partner closely with Manufacturing, Quality, Clinical Operations, and Program Management to deliver critical regulatory milestones
- Drive execution of regulatory policies, processes, and best practices to ensure consistent, compliant, and efficient regulatory operations
Requirements
- Strong working knowledge of FDA regulations, ICH guidelines, and global CMC regulatory requirements
- Extensive experience with CTD structure, content, and global submission requirements
- Strong strategic thinking skills with the ability to balance scientific, regulatory, and business considerations
- Demonstrated ability to influence cross-functional stakeholders and senior leaders without direct authority
Nice to have
- Bachelor's degree in life sciences or a related scientific discipline required
- advanced degree preferred
- Demonstrated experience leading CMC sections of biologics marketing applications (BLA/MAA) strongly preferred
- Experience in rare disease drug development preferred
- Experience with EU and international regulatory frameworks related to clinical and commercial development is a plus
Benefits
- 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
- Mentor and support the development of regulatory team members, fostering a culture of collaboration, accountability, and continuous learning
Company info
- We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease.
- At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.
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