Associate Director, Regulatory Labeling and Disclosures
Sarepta Therapeutics · US
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Role summary
This role leads global labeling and disclosure activities for development and marketed genetic medicine products. The Associate Director develops and maintains prescribing information, core data sheets, and regulatory documents across regions while managing clinical trial registration and database submissions. The position requires cross-functional collaboration with internal teams and external partners to balance regulatory compliance with business objectives.
What they're looking for
- Bachelor's degree in related scientific field
- 10+ years regulatory labeling and/or clinical trial disclosure experience
- Proficiency with Microsoft Office and regulatory information systems
- Experience with Health Authority labeling negotiations
- Knowledge of evolving regulatory guidance and compliance requirements
What you'll be doing
- Lead cross-functional teams developing US prescribing information and global labeling documents
- Maintain compliance with regulatory requirements for core data sheets and regional labeling adaptations
- Coordinate clinical trial registration, redaction, and results posting to regulatory databases worldwide
- Manage individual participant data report generation and external requests at study completion
- Partner with internal teams and external vendors on labeling strategy and Health Authority submissions
Privacy & handoff
This role links to Sarepta Therapeutics's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.