Global Regulatory Strategy Lead — Remote

Sarepta Therapeutics; New York (NY); Hybrid; USD 116,000 - 145,000; Full time

Benefits offered by this job

Wellness benefits

Financial wellbeing

Caregiver support

Job summary

Sarepta Therapeutics is seeking a Regulatory Affairs Lead based in the United States. This hybrid role involves leading regulatory submissions for multiple programs, coordinating with cross-functional teams, and supporting lifecycle activities across markets.

The position emphasizes strong communication and strategic regulatory thinking. The incumbent will work with Global Regulatory and RA CROs, ensuring timely and compliant submissions while maintaining regulatory intelligence and guidelines.

Qualifications

• BS or equivalent with 5+ years of regulatory experience.
• MS in Regulatory Affairs or RAC.
• Experience preparing submissions for regulatory authorities.
• Knowledge of ICH guidelines, IND/CTA, and Orphan drug designation.
• Strong communication and multitasking abilities.
• Experience in cross-functional project teams.
• High ethical standards with attention to detail.
• Proficiency with MS Office applications.

Responsibilities

• Act as regulatory lead for clinical trial activities and submissions.
• Review regulatory submission materials for CRO-submitted documents.
• Implement regulatory activities across product lifecycles in assigned markets.
• Prepare country-specific submissions and maintain regulatory documentation.
• Contribute to regulatory strategy across global teams and markets.
• Collaborate with RA CROs to maintain trial progression and compliance.
• Provide regulatory guidance across cross-functional teams and updates.

Skills

Regulatory knowledge

ICH guidelines

Submission planning

Cross-functional teamwork

Communication skills

Project management

MS Office

Education

BS or equivalent with 5+ years of regulatory experience

MS in Regulatory Affairs or RAC

Tools

Microsoft Office

Job description

Sarepta Therapeutics is seeking a Regulatory Affairs Lead based in the United States. This hybrid role involves leading regulatory submissions for multiple programs, coordinating with cross-functional teams, and supporting lifecycle activities across markets.

The position emphasizes strong communication and strategic regulatory thinking. The incumbent will work with Global Regulatory and RA CROs, ensuring timely and compliant submissions while maintaining regulatory intelligence and guidelines.