Director, Regulatory Affairs

REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.

As the Director, Regulatory Affairs, you will develops and executes global regulatory strategies for early-stage and advanced therapy products, preparing key submissions and ensuring alignment with U.S. and international requirements. You’ll also monitor and interpret evolving regulatory and policy landscapes, engage with external stakeholders, and contribute to industry workgroups to inform development pathways. Additionally, you will build internal regulatory intelligence resources and partner cross-functionally to guide successful progression through pre-IND/CTA stages and the product lifecycle.