Senior Regulatory Labeling & Disclosures Lead — Remote

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

Benefits offered by this job

Physical and Emotional Wellness

Financial Wellness

Support for Caregivers

Job summary

Sarepta Therapeutics seeks an Associate Director of Regulatory Labeling and Disclosures to lead global labeling activities for development and marketed products and to oversee disclosures for applicable clinical trials. The role is US remote-based with potential on-site collaboration and cross-functional engagement.

The position emphasizes CCDS/local labeling, regulatory strategy, and HA interactions, requiring strong leadership and collaboration.

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 for US Full Prescribing Information and CCDS.
• Develop global labeling strategy and assist regional labeling efforts.
• Support regulatory submissions, labeling negotiations with Health Authorities.
• Coordinate clinical trial registrations and results postings.
• Manage IPD requests and ensure disclosure compliance.
• Maintain regulatory documents and SOP compliance.

Skills

Regulatory labeling

Cross-functional collaboration

Microsoft Office

Education

BS in related field

Tools

Regulatory systems

Job description

Sarepta Therapeutics seeks an Associate Director of Regulatory Labeling and Disclosures to lead global labeling activities for development and marketed products and to oversee disclosures for applicable clinical trials. The role is US remote-based with potential on-site collaboration and cross-functional engagement.

The position emphasizes CCDS/local labeling, regulatory strategy, and HA interactions, requiring strong leadership and collaboration.