Remote Global Regulatory Labeling & Disclosures Lead

Sarepta Therapeutics; Washington (District of Columbia); 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 is seeking an Associate Director of Regulatory Labeling and Disclosures based in the United States with a remote/hybrid work setup. The role leads global labeling activities for development and marketed products, and oversees disclosures for clinical trials.

The position collaborates with internal teams and external partners to ensure regulatory compliance and lifecycle management. Key responsibilities include development and maintenance of CCDS, US FPI, and TPL, plus

Qualifications

• BS in related field with 10+ years of related experience. Strong scientific education preferred.
• Experience in Regulatory Labeling and/or Disclosures, preferred
• Proficiency with Microsoft Office Applications; Word, Excel, Outlook, and regulatory systems.

Responsibilities

• Leads cross-functional labeling teams to develop and maintain US Full Prescribing Information and associated local labeling documents, CCDS, and TPL for marketed and development products.
• Contributes to global labeling strategy and assists international regulatory colleagues with local labeling.
• Ensures regulatory integrity and consistency in communications and activities while supporting business goals.
• Coordinates labeling updates and maintenance, including artwork collaboration as needed.
• Supports HA interactions with labeling strategy, submissions, and responses.

Skills

Regulatory labeling

Regulatory disclosures

Cross-functional leadership

HA interactions

Regulatory strategy

Education

Bachelor's degree

Tools

Microsoft Office

Regulatory systems

Job description

Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures based in the United States with a remote/hybrid work setup. The role leads global labeling activities for development and marketed products, and oversees disclosures for clinical trials.

The position collaborates with internal teams and external partners to ensure regulatory compliance and lifecycle management. Key responsibilities include development and maintenance of CCDS, US FPI, and TPL, plus