Associate Director, Regulatory Labeling and Disclosures

About the role

Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

The Importance of the Role: The Associate Director of Regulatory Labeling and Disclosures is a US remote based position. You will be responsible for leading global labeling activities for development and/or marketed products, and leading disclosure activities for applicable clinical trials. The Associate Director is responsible for the development, maintenance, and harmonization of core labeling (e.g., CCDS) and local labeling, ensuring compliance with applicable regulatory requirements while supporting business and lifecycle objectives. The Associate Director may also oversee the end-to-end operations for clinical trial registration, maintenance and results posting on Health Authority‑managed databases worldwide (e.g., Clinicaltrials.gov, EudraCT). The Associate Director is responsible for effectively partnering and engaging with internal (e.g., cross‑functional study teams, senior management) and external key stakeholders (e.g., vendors, business partners) to ensure business needs and regulatory requirements