Remote Associate Director, Global Labeling & Disclosures

Sarepta Therapeutics; Ohio; 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 to lead global labeling activities for development and marketed products and manage disclosure of clinical trial data.

This US remote-based position coordinates with cross-functional teams, vendors, and Health Authorities to ensure compliant labeling while supporting lifecycle objectives; hybrid work expectations are noted.

Qualifications

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

Responsibilities

• Leads cross-functional labeling teams to develop US Full Prescribing Information and CCDS.
• Supports global labeling strategy and local labeling harmonization.
• Ensures regulatory integrity and consistency in communications and activities.
• Maintains alignment between reference labeling and regional adaptations.
• Collaborates on package labeling development, updates, and maintenance.
• Supports IPD disclosures and health authority submissions as needed.
• Manages IPD requests with Sarepta privacy team.
• Maintains documentation compliant with Sarepta SOPs.

Skills

Regulatory labeling experience

Disclosures experience

MS Office proficiency

Education

Bachelor's degree in related field

Tools

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 manage disclosure of clinical trial data.

This US remote-based position coordinates with cross-functional teams, vendors, and Health Authorities to ensure compliant labeling while supporting lifecycle objectives; hybrid work expectations are noted.