Global Regulatory Labeling & Disclosures Leader

Sarepta Therapeutics; Cambridge (MA); On-site; 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. You will partner with cross-functional teams to ensure compliant labeling, CCDS, and local labeling across regions.

This on-site role offers the opportunity to shape regulatory strategy, manage IPD disclosures, and collaborate with Health Authorities and external vendors.

Qualifications

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

Responsibilities

• Lead cross-functional labeling teams to develop US Full Prescribing Information and CCDS, and Target Product Labeling for marketed and development products.
• Contribute to global labeling strategy and assist international regulatory colleagues in development of local or regional labeling.
• Coordinate clinical trial registration, maintenance and results posting on Health Authority databases (e.g., Clinicaltrials.gov, EU CTIS).
• Manage process for IPD report generation and respond to external IPD requests.
• Build and maintain relationships with Global Regulatory Affairs, cross functional contributors, and external vendors to support regulatory disclosure and transparency compliance.

Skills

Regulatory labeling

Disclosures/registrations

Cross-functional collaboration

Education

BS in related field

Tools

Microsoft Office Applications

Job description

Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures to lead global labeling activities for development and marketed products. You will partner with cross-functional teams to ensure compliant labeling, CCDS, and local labeling across regions.

This on-site role offers the opportunity to shape regulatory strategy, manage IPD disclosures, and collaborate with Health Authorities and external vendors.