Director, Regulatory CMC

The Director, Regulatory CMC is responsible for defining and executing global CMC regulatory strategies for Dyne programs across all stages of development. This role plays a critical leadership role in enabling clinical registration, commercial readiness, and manufacturing lifecycle management.

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
• Strong working knowledge of FDA regulations, ICH guidelines, and global CMC regulatory requirements
• 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

Benefits

• Paid Time Off
• 401k Matching
• Health Insurance
• Dental Insurance
• Vision Insurance