Remote Associate Director, Labeling & Disclosures

Sarepta Therapeutics; Denver (CO); Hybrid; USD 161,000 - 201,000; Full time

Benefits offered by this job

Physical and Emotional Wellness

Financial Wellness

Caregiver Support

Job summary

Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures for a US remote-based role with hybrid on-site requirements. You will lead cross-functional labeling programs, manage CCDS and TPL, and support global labeling strategies while coordinating clinical trial registrations and disclosures.

The position requires a strong background in regulatory labeling, collaboration with Health Authorities, and experience with regulatory strategy.

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 global labeling activities for development and/or marketed products (US Full Prescribing Information, CCDS, TPL).
• Oversee clinical trial registrations and results postings on Health Authority databases.
• Coordinate with cross-functional teams and external partners to ensure regulatory compliance and transparency.

Skills

Regulatory labeling experience

Cross-functional collaboration

Regulatory strategy

Education

BS in related field

Tools

Microsoft Word

Microsoft Excel

Regulatory systems

Job description

Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures for a US remote-based role with hybrid on-site requirements. You will lead cross-functional labeling programs, manage CCDS and TPL, and support global labeling strategies while coordinating clinical trial registrations and disclosures.

The position requires a strong background in regulatory labeling, collaboration with Health Authorities, and experience with regulatory strategy.