Executive Director, Regulatory Affairs

Responsibilities

• Shape and lead comprehensive global regulatory strategy for Dyne programs
• Provide strategic oversight of the regulatory function through functional managers
• Lead interactions with global health authorities including FDA and EMA
• Oversee preparation and submission of major regulatory filings such as INDs, CTAs, NDAs, BLAs, and MAAs
• Direct regulatory strategy for expedited programs and designations like Orphan Drug and Breakthrough Therapy
• Lead regulatory inspections and audits
• Mentor the regulatory affairs team and lead talent development initiatives
• Collaborate cross-functionally for successful product development and launch

Requirements

• Bachelor's degree in life sciences or related discipline
• 18+ years of progressive experience in regulatory affairs
• Minimum of 10 years in management or leadership roles
• Deep expertise in regulatory strategy for clinical-stage biotechnology companies
• Strong experience in CTD format and content for regulatory filings
• Demonstrated knowledge of FDA, EMA, and international regulations (clinical, nonclinical, and CMC)
• Experience leading health authority meetings and negotiating with regulatory agencies
• Outstanding regulatory writing and communication skills

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 FSHD and Pompe disease.