Remote Regulatory Labeling & Disclosures Lead

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

Benefits offered by this job

Wellness program

Financial wellness

Caregiver support

Job summary

Sarepta Therapeutics is seeking 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. This is a US remote-based position with hybrid expectations at Sarepta facilities.

You will partner with cross-functional teams and external partners to ensure regulatory compliance, manage submissions to Health Authorities, and maintain CCDS and product labeling across

Qualifications

• BS in related field with 10+ years of regulatory labeling/disclosures experience.
• Experience in developing core and local labeling and label negotiations with Health Authorities.
• Proficiency with Microsoft Office Applications and regulatory systems.

Responsibilities

• Lead cross-functional labeling teams to develop and maintain US Full Prescribing Information, CCDS, and TPL for products.
• Contribute to global labeling strategy and align local labeling with reference labeling.
• Ensure regulatory integrity and compliant communications across regions and teams.
• Coordinate clinical trial registrations and results postings in regulatory databases.

Skills

Regulatory labeling

Regulatory disclosures

Cross-functional collaboration

Project management

Regulatory strategy

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 to lead global labeling activities for development and marketed products and to oversee disclosures for applicable clinical trials. This is a US remote-based position with hybrid expectations at Sarepta facilities.

You will partner with cross-functional teams and external partners to ensure regulatory compliance, manage submissions to Health Authorities, and maintain CCDS and product labeling across