Director, Regulatory CMC

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
• Serve as the CMC regulatory strategist and program leader, identifying regulatory risks and mitigation strategies
• Provide strategic regulatory guidance to Manufacturing and Quality organizations to ensure global compliance
• Oversee the planning, development, and delivery of high-quality CMC sections for global regulatory submissions
• Coordinate and manage global regulatory submissions, maintenance of product registrations, and change control activities
• Act as the primary CMC Regulatory Affairs point of contact for cross-functional teams
• Mentor and support the development of regulatory team members

Requirements

• Bachelor’s degree in life sciences or a related scientific discipline
• 10+ years of experience in the biotech or pharmaceutical industry
• Minimum of 7 years in Regulatory Affairs, including significant CMC regulatory experience
• Strong working knowledge of FDA regulations, ICH guidelines, and global CMC regulatory requirements
• Extensive experience with CTD structure, content, and global submission requirements
• Proven ability to manage multiple complex programs in a fast-paced environment
• Exceptional written and verbal communication skills

Preferred Qualifications

• Advanced degree in a scientific discipline
• Demonstrated experience leading CMC sections of biologics marketing applications (BLA/MAA)
• Experience in rare disease drug development
• Experience with EU and international regulatory frameworks

About the Company

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 preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.