Executive Director, Regulatory Affairs

Role: Executive Director of Regulatory Affairs, leading global regulatory strategy for Dyne's neuromuscular disease programs. Responsibilities: develop long-term regulatory plans aligned with corporate goals; oversee interactions with agencies like FDA and EMA; manage regulatory filings including INDs, NDAs, and designations such as Orphan Drug or Fast Track; and shape organizational policies. Provide strategic oversight across teams, foster innovation, lead talent development, and ensure compliance throughout product lifecycle. Collaborate with executive stakeholders on enterprise-wide regulatory matters and influence regulatory pathways for clinical-stage biologics addressing diseases like DMD and DM1. Requirements: Bachelor's in life sciences (Master's preferred); 18+ years in regulatory affairs with at least 10 years in leadership roles; deep expertise in biotech regulatory strategy, CTD submissions, and international health authority regulations; proven experience in health authority negotiations and regulatory inspections; exceptional communication skills. HighValue: biologics for neuromuscular disorders, clinical-stage development, global regulatory agency engagement, strategic regulatory planning, cross-functional leadership, and team mentorship. Location: Waltham, MA.