Global Regulatory Labeling & Disclosures Director — Remote

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

Job summary

Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures (US remote, hybrid). You will lead global labeling activities, including CCDS and local labeling, and coordinate trial registrations and results postings across Health Authorities worldwide.

You will partner with cross-functional teams to ensure regulatory compliance while supporting lifecycle objectives, with a focus on strategic labeling and disclosure initiatives.

Qualifications

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

Responsibilities

• Lead US labeling activities including CCDS and TPL for products.
• Develop global labeling strategy and support regional labeling.
• Coordinate clinical trial registrations and results postings.
• Ensure regulatory compliance and effective stakeholder communications.

Skills

Regulatory labeling

Label negotiations

Cross-functional collaboration

Education

Bachelor's degree in related field

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Regulatory systems

Job description

Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures (US remote, hybrid). You will lead global labeling activities, including CCDS and local labeling, and coordinate trial registrations and results postings across Health Authorities worldwide.

You will partner with cross-functional teams to ensure regulatory compliance while supporting lifecycle objectives, with a focus on strategic labeling and disclosure initiatives.