Remote Global Regulatory Labeling & Disclosures Lead

Sarepta Therapeutics; Kentucky; Hybrid; USD 161,000 - 201,000; Full time

Job summary

Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures. This US remote-based role leads labeling across products, harmonizes CCDS and local labeling, and oversees clinical trial registrations and results postings.

You’ll partner with internal teams and external partners to ensure regulatory compliance and alignment with business goals. The position is hybrid, with on-site requirements at Sarepta facilities in the United States and events as needed.

Qualifications

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

Responsibilities

• Leads cross-functional labeling teams to develop and maintain US Full Prescribing Information and CCDS.
• Contributes to global labeling strategy and local labeling alignment.
• Manages regulatory data disclosure for clinical trials and IPD requests.
• Supports HA interactions and labeling submissions and negotiations.
• Ensures regulatory documentation is compliant with Sarepta SOPs.

Skills

Regulatory labeling

Disclosures (ClinicalTrials)

Cross-functional leadership

Regulatory strategy

Education

BS in related field

Tools

Microsoft Office

Job description

Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures. This US remote-based role leads labeling across products, harmonizes CCDS and local labeling, and oversees clinical trial registrations and results postings.

You’ll partner with internal teams and external partners to ensure regulatory compliance and alignment with business goals. The position is hybrid, with on-site requirements at Sarepta facilities in the United States and events as needed.