Global Regulatory Labeling Director - Remote

Regulatory Jobs; United States; Hybrid; USD 161,000 - 201,000; Full time

Job summary

Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures for a US-remote role with hybrid work. You will lead global labeling activities, ensure local labeling compliance, and manage disclosures for clinical trials, working with cross-functional teams and external partners.

The role emphasizes strategic labeling, health authority interactions, and end-to-end regulatory operations, with a focus on robust compliance and lifecycle management.

Qualifications

• 10+ years of related experience in regulatory labeling or disclosures preferred
• Proficiency with Microsoft Office applications (Word, Excel, Outlook) 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 ensure local/regional labeling consistency.
• Coordinate with HA on labeling strategy, submissions, and questions.
• Oversee/coordinate clinical trial registrations and results postings (ClinicalTrials.gov, EU CTIS).
• Manage IPD requests through Sarepta's privacy team.
• Build relationships with Global Regulatory Affairs and external vendors for compliance and disclosures.
• Ensure documentation management and regulatory SOP alignment.

Skills

Regulatory labeling experience

MS Office

Regulatory systems

Education

BS in related field

Tools

Regulatory systems

Job description

Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures for a US-remote role with hybrid work. You will lead global labeling activities, ensure local labeling compliance, and manage disclosures for clinical trials, working with cross-functional teams and external partners.

The role emphasizes strategic labeling, health authority interactions, and end-to-end regulatory operations, with a focus on robust compliance and lifecycle management.