Associate Director, GRA

Sarepta Therapeutics seeks an Associate Director of Global Regulatory Affairs to lead regulatory strategy and health authority interactions for genetic medicine programs. The role involves developing submissions, overseeing junior staff, and ensuring compliance across clinical development and commercialization activities.

Responsibilities

• Develop and execute regulatory strategies incorporating clinical, nonclinical, and CMC data to support health authority interactions
• Serve as primary contact for FDA and global health authority meetings, representing Sarepta throughout regulatory engagement
• Lead preparation and quality assurance of regulatory submissions including INDs, CTAs, NDAs, and correspondence
• Oversee activities and performance of junior regulatory personnel and coordinate multi-disciplinary regulatory teams
• Facilitate risk identification and mitigation strategies while managing budgets and contractual obligations

Requirements

• Bachelor's degree or equivalent with 10+ years of related regulatory experience
• Prior regulatory affairs experience in major pharmaceutical markets
• Knowledge of clinical and nonclinical data requirements for product labeling
• Experience preparing regulatory submissions and briefing packages for agency meetings
• Strong communication skills on regulatory topics internally and externally
• Leadership ability to align divergent perspectives and drive cross-functional engagement
• Flexibility and adaptability to changing circumstances and ambiguity

Compensation: $160,800 - $201,000 per year