Global Regulatory Labeling & Disclosures Lead

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

Job summary

Sarepta Therapeutics is seeking an Associate Director, Regulatory Labeling and Disclosures, to lead global labeling activities and disclosure programs. The role focuses on developing and harmonizing core labeling and local labeling while ensuring regulatory compliance and alignment with lifecycle objectives.

The position involves coordinating global labeling strategy, managing submissions to Health Authorities, and overseeing clinical trial registrations and results postings.

Qualifications

• BS in related field with 10+ years of experience.
• Experience in Regulatory Labeling and/or Disclosures preferred.
• Proficiency with Microsoft Office applications 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 local labeling development.
• Ensure regulatory integrity and alignment between reference labeling and regional adaptations.
• Coordinate clinical trial registration, maintenance, and results postings on global databases (e.g., ClinicalTrials.gov, EU CTIS).
• Manage IPD report generation and respond to external IPD requests with Sarepta privacy.

Skills

Regulatory labeling

Disclosures management

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, Regulatory Labeling and Disclosures, to lead global labeling activities and disclosure programs. The role focuses on developing and harmonizing core labeling and local labeling while ensuring regulatory compliance and alignment with lifecycle objectives.

The position involves coordinating global labeling strategy, managing submissions to Health Authorities, and overseeing clinical trial registrations and results postings.