Senior Regulatory Labeling & Disclosures Lead (Remote)

Sarepta Therapeutics; California (MO); 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 in the United States is seeking an Associate Director of Regulatory Labeling and Disclosures for a US remote based position with hybrid on-site expectations. You will lead global labeling activities, harmonize CCDS and local labeling, and oversee trial registrations and results postings.

This role requires strong cross-functional leadership, regulatory strategy, and engagement with Health Authorities, vendors, and study teams. Salary range: $160,800–$201,000/year.

Qualifications

• BS in related field with 10+ years of regulatory labeling experience.
• Experience in labeling and/or disclosures with Health Authorities.
• Proficient in Microsoft Office and regulatory systems.

Responsibilities

• Lead cross-functional labeling teams for US Full Prescribing Information and CCDS.
• Develop global labeling strategy and assist regional labeling.
• Coordinate clinical trial registrations and results postings.

Skills

Regulatory labeling

Cross-functional leadership

Clinical trial disclosure

MS Office

Education

B.S. in related field

Tools

Microsoft Word

Microsoft Excel

Outlook

Job description

Sarepta Therapeutics in the United States is seeking an Associate Director of Regulatory Labeling and Disclosures for a US remote based position with hybrid on-site expectations. You will lead global labeling activities, harmonize CCDS and local labeling, and oversee trial registrations and results postings.

This role requires strong cross-functional leadership, regulatory strategy, and engagement with Health Authorities, vendors, and study teams. Salary range: $160,800–$201,000/year.