Associate Director, GRA

Role: Global Regulatory Lead responsible for developing and executing regulatory strategies to support Sarepta's therapeutic programs, primarily in gene therapy and rare diseases such as Duchenne muscular dystrophy. Responsibilities include preparing high-quality regulatory submissions (INDs, CTAs, NDAs), leading interactions with global health authorities (including FDA), and guiding cross-functional teams on regulatory pathways. The role entails managing regulatory documentation, overseeing junior staff, and ensuring compliance with evolving regulations to maximize development and commercialization success. Qualifications: BS or equivalent with 10+ years of regulatory affairs experience, including in major markets; deep understanding of drug development processes, including clinical, nonclinical, and CMC aspects. Skills include strategic planning, excellent communication, leadership without authority, and adaptability. Preferred: experience with biologics, gene therapies, or rare disease programs, and a track record of successful regulatory interactions. High-value specifics: focus on gene therapy, rare diseases, global regulatory strategy, and experience with FDA interactions. Work setup: hybrid (onsite and remote) in the U.S.; some in-person attendance at Sarepta facilities is expected.