Remote Global Regulatory Strategy Lead

Sarepta Therapeutics; Connecticut; Hybrid; USD 116,000 - 145,000; Full time

Job summary

Sarepta Therapeutics is seeking a Regulatory Affairs professional to lead regulatory activities for clinical trials in the United States and other markets. You will review submissions, coordinate with CROs, and support lifecycle regulatory activities across markets.

You will contribute to global regulatory strategy, stay current with evolving regulations, and ensure compliant documentation in line with Sarepta SOPs. This is a hybrid US-based role with on-site collaboration at Sarepta facilities.

Qualifications

• Understanding of regulatory submission requirements across multiple markets.
• Experience preparing submissions with clear content and formats.
• Strong written and verbal communication skills.

Responsibilities

• Lead regulatory activities for clinical trials in assigned markets.
• Review regulatory submissions and coordinate CRO inputs.
• Support product lifecycle regulatory activities across markets.
• Prepare country-specific submissions and timelines.
• Contribute to global regulatory strategy and cross-functional teams.
• Ensure documentation is compliant with Sarepta SOPs.

Skills

Drug development knowledge

Regulatory process knowledge

ICH guidelines & IND/CTA

Submission preparation

Adaptive communication

Multi-tasking & project management

Cross-functional teamwork

Attention to detail & ethics

MS Office proficiency

CRO collaboration

Education

BS or equivalent with 5+ years regulatory experience

MS in Regulatory Affairs or RAC

Job description

Sarepta Therapeutics is seeking a Regulatory Affairs professional to lead regulatory activities for clinical trials in the United States and other markets. You will review submissions, coordinate with CROs, and support lifecycle regulatory activities across markets.

You will contribute to global regulatory strategy, stay current with evolving regulations, and ensure compliant documentation in line with Sarepta SOPs. This is a hybrid US-based role with on-site collaboration at Sarepta facilities.