Associate Director, Regulatory Labeling and Disclosures

About the role

Sarepta is a leader in genetic medicine, with a strong presence in Duchenne muscular dystrophy and a growing portfolio across muscle, central nervous system, and cardiac diseases. In 2023 the company launched its fourth therapy and the first ever gene therapy for Duchenne. The Associate Director of Regulatory Labeling and Disclosures is a US‑based remote role responsible for leading global labeling activities for development and/or marketed products and overseeing disclosure activities for applicable clinical trials. The position drives the development, maintenance, and harmonization of core labeling (CCDS) and local labeling, ensures regulatory compliance, supports business and lifecycle objectives, and partners with cross‑functional teams and external stakeholders to meet business needs and regulatory requirements.

Responsibilities

• Leads cross-functional labeling teams to develop and maintain US Full Prescribing Information and associated local labeling documents, Company Core Data Sheets (CCDS), and Target Product Labeling (TPL) for marketed and development products
• Contributes to the formulation of global labeling strategy and assists international regulatory colleagues in development of local or regional labeling consistent with reference labeling
• Responsive to business goals offering creative and compliant solutions while ensuring company regulatory integrity and consistency in communications and activities
• Ensures alignment between reference labeling and regional adaptations while supporting affiliate needs
• Collaborates with cross-functional leads on package labeling (artwork) development, updates, and maintenance
• Supports Global Regulatory Strategists with HA interaction labeling strategy, including submissions, responses to questions, and negotiations
• May lead or support coordinating activities for clinical trial registration, including redactions of clinical trial documents, registration maintenance and results posting to clinicaltrials.gov, EU CTIS, and similar databases worldwide in compliance with procedures and applicable regulations
• Manages process for individual participant data (IPD) report generation at the end of clinical studies and acts as point of contact for external IPD requests received through Sarepta's privacy team
• Builds and maintains relationships with the Global Regulatory Affairs team, cross‑functional contributors, and external vendors to support effective, efficient communication and maintain clinical trial disclosure and transparency compliance, accuracy, and completeness
• Involved in developing, modifying, and executing company policies that affect immediate operations and may also have company‑wide effect
• Ensures documentation management and record keeping are compliant with regulatory expectations and Sarepta SOPs
• Maintains knowledge of relevant evolving regulation and guidance
• Key contributor within Global Regulatory Teams to establish and implement regulatory strategy
• Interacts across levels and line functions to lead team through successful engagements with Health Authorities

Requirements

BS in a related field with 10+ years of related experience; strong scientific education preferred. Experience in regulatory labeling (e.g., developing core and local labeling, label negotiations with Health Authorities) and/or disclosures (e.g., publishing applicable clinical trial registrations and/or results) preferred. Proficiency with Microsoft Office applications (Word, Excel, Outlook) and regulatory systems. Candidates must be authorized to work in the U.S.

Benefits

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

For a full list of our comprehensive benefits, see our website: