Global Regulatory Strategy Lead (Remote)

Sarepta Therapeutics; Rhode Island; 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 to lead registration activities for clinical trials and market submissions in the United States. You will coordinate with CROs, ensure regulatory compliance, and support lifecycle regulatory strategies across assigned markets.

The role requires a BS with 5+ years of experience and an MS or RAC in Regulatory Affairs. This US-based, hybrid position offers competitive salary and comprehensive benefits.

Qualifications

• Experience with regulatory submissions and formats
• Understanding of submission content
• Ability to work in cross-functional teams with strong interpersonal skills

Responsibilities

• Act as regulatory lead for clinical trial activities and related submissions
• Review regulatory materials for CRO-submitted work
• Support regulatory strategy for assigned markets across lifecycle
• Prepare country-specific submissions and maintain regulatory documents
• Provide guidance on clinical trial activity and cross-functionally update stakeholders
• Maintain knowledge of evolving regulations and Sarepta SOPs
• Escalate issues to RA stakeholders and ensure compliance

Skills

Drug development

ICH guidelines

Submission preparation

Cross-functional communication

multitask management

Cross-functional teams

Accountability & ethics

MS Office (Word, Excel, Outlook)

Education

BS or equivalent with 5+ years

MS in Regulatory Affairs or RAC

Tools

MS Word

Excel

Outlook

Adobe Suite

Job description

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

The role requires a BS with 5+ years of experience and an MS or RAC in Regulatory Affairs. This US-based, hybrid position offers competitive salary and comprehensive benefits.