Remote Associate Director, Regulatory Labeling&Disclosures

Sarepta Therapeutics; Illinois; Remote; USD 161,000 - 201,000; Full time

Benefits offered by this job

Physical & Emotional Wellness

Financial Wellness

Support for Caregivers

Job summary

Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures for a US remote role. You will lead global labeling activities, manage CCDS, and oversee local labeling while ensuring regulatory compliance across markets.

You will partner with cross-functional study teams, senior management, and external partners, contributing to regulatory strategy and clinical trial disclosures. The role demands a strong background in labeling and data transparency.

Qualifications

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

Responsibilities

• Lead cross-functional labeling teams to develop US Full Prescribing Information, CCDS, and Target Product Labeling for products.
• Contribute to global labeling strategy and assist international colleagues with local labeling.
• Provide compliant regulatory solutions aligned with business goals and lifecycle objectives.
• Coordinate with affiliates to ensure regional labeling meets reference labeling while maintaining consistency.
• Support IPD data requests and external disclosures as needed.

Skills

Regulatory labeling

Cross-functional collaboration

IPD disclosures coordination

Regulatory strategy

MS Office proficiency

Education

BS in related field

Tools

Regulatory systems

Job description

Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures for a US remote role. You will lead global labeling activities, manage CCDS, and oversee local labeling while ensuring regulatory compliance across markets.

You will partner with cross-functional study teams, senior management, and external partners, contributing to regulatory strategy and clinical trial disclosures. The role demands a strong background in labeling and data transparency.