Regulatory Labeling & Disclosures Lead (Remote)

Sarepta Therapeutics; New York (NY); Hybrid; USD 161,000 - 201,000; Full time

Job summary

Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures to lead global labeling activities for development and marketed products from a US remote-based position. The role emphasizes compliant labeling, IPD and clinical trial disclosures, and collaboration with internal and external stakeholders.

The position requires a strong regulatory background, extensive experience in labeling and disclosures, and ability to partner with Health Authorities.

Qualifications

• BS in related field with 10+ years of related experience preferred.
• Experience in Regulatory Labeling and/or Disclosures is preferred.
• Proficiency with Microsoft Office Applications; Word, Excel, Outlook, and regulatory systems.

Responsibilities

• Leads cross-functional labeling teams to develop US Full Prescribing Information and CCDS.
• Contributes to global labeling strategy and local labeling alignment.
• Manages regulatory labeling activities to ensure compliance and lifecycle objectives.

Skills

Regulatory labeling

Disclosures

Cross-functional collaboration

Education

BS in related field

Tools

MS Office

Regulatory systems

Job description

Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures to lead global labeling activities for development and marketed products from a US remote-based position. The role emphasizes compliant labeling, IPD and clinical trial disclosures, and collaboration with internal and external stakeholders.

The position requires a strong regulatory background, extensive experience in labeling and disclosures, and ability to partner with Health Authorities.