Manager, Global Regulatory Strategy

Sarepta Therapeutics seeks a Manager of Global Regulatory Strategy to lead regulatory affairs for clinical trials and product registration across multiple genetic medicine programs. The role involves managing submissions, coordinating with cross-functional teams, and supporting lifecycle activities for assigned markets and products.

Responsibilities

• Lead regulatory affairs for clinical trial activities including CTA planning, agency query response, and label review
• Review and oversee regulatory submissions prepared by contract research organizations
• Execute regulatory lifecycle activities and prepare country-specific submissions for assigned markets
• Provide regulatory guidance to cross-functional teams and maintain compliance with documentation standards
• Contribute to global regulatory strategy development and participate in regulatory team discussions

Requirements

• Bachelor's degree or equivalent qualification
• 5–8 years of drug development and regulatory experience
• Knowledge of ICH guidelines, IND/CTA, IMPDs, and orphan drug processes
• Demonstrated experience preparing regulatory submissions with clear understanding of content and format
• Strong multi-tasking, prioritization, and project management capabilities
• Proficiency with Microsoft Office and Adobe Suite applications

Compensation: $116,000–$145,000 per year