Global Regulatory Strategy Lead - Remote

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

Benefits offered by this job

Physical and Emotional Wellness

Financial Wellness

Support for Caregivers

Job summary

Sarepta Therapeutics is seeking a Regulatory Affairs professional in the United States for a hybrid remote/on-site role. You will lead regulatory activities for clinical trials, reviews, and submissions, and support global strategy across markets.

A BS+ with 5+ years of regulatory experience and an MS/RAC are preferred, with strong cross-functional collaboration and communication. The position emphasizes maintaining regulatory compliance, strategizing for assigned products, and coordinating with

Qualifications

• Knowledge of drug development and regulatory process.
• Experience preparing submissions with understanding of content and format.
• Adaptive communication skills for interpersonal, written, and verbal exchange.
• Ability to multi-task, prioritize, manage timelines, and track complex information.
• Experience working in cross-functional project teams.
• High ethical standards with attention to quality and detail.

Responsibilities

• Act as regulatory affairs clinical lead for trial activities including planning, responses, and submissions.
• Review regulatory submission materials for CRO-conducted submissions.
• Support regulatory activities across product lifecycles for assigned markets.
• Ensure country-specific submissions are assembled and prepared.
• Collaborate with Global Regulatory Lead to define and communicate regulatory strategy.
• Contribute to global regulatory strategy and participate in Global Regulatory Teams.
• Coordinate with RA CRO to maintain trial progression and compliance.
• Provide regulatory guidance and update cross-functionally as needed.

Skills

Regulatory knowledge

IND/CTA submissions

ICH guidelines

Cross-functional collaboration

Project management

Clear communication

MS Office proficiency

Regulatory strategy

Education

BS or equivalent with 5+ years of experience

MS in Regulatory Affairs or RAC

Tools

Microsoft Office Suite

Job description

Sarepta Therapeutics is seeking a Regulatory Affairs professional in the United States for a hybrid remote/on-site role. You will lead regulatory activities for clinical trials, reviews, and submissions, and support global strategy across markets.

A BS+ with 5+ years of regulatory experience and an MS/RAC are preferred, with strong cross-functional collaboration and communication. The position emphasizes maintaining regulatory compliance, strategizing for assigned products, and coordinating with