Global Labeling & Disclosures Lead (Remote)

Sarepta Therapeutics; Chicago (IL); 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, a leader in genetic medicine, seeks an Associate Director of Regulatory Labeling and Disclosures. The role leads global labeling activities, ensuring CCDS and local labeling compliance while coordinating trial registrations and results postings.

Ideal candidates bring 10+ years in regulatory labeling or disclosures, with strong MS Office skills and cross-functional collaboration experience. This is a hybrid US-based role with competitive compensation.

Qualifications

• BS in related field with 10+ years of related experience; strong scientific education preferred.
• Experience in Regulatory Labeling and/or Disclosures (publishing clinical trial registrations and/or results) 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, CCDS, and TPL for marketed and development products.
• Contributes to global labeling strategy and assists international regulatory colleagues in local labeling development.
• Ensures regulatory integrity and aligns labeling with regional adaptations while supporting affiliate needs.
• Collaborates on package labeling development, updates, and maintenance with cross-functional teams.
• Supports HA interactions labeling strategy, including submissions and responses to questions.
• Manages clinical trial registration and results postings on Clinicaltrials.gov, EU CTIS, and similar databases.

Job description

Sarepta Therapeutics, a leader in genetic medicine, seeks an Associate Director of Regulatory Labeling and Disclosures. The role leads global labeling activities, ensuring CCDS and local labeling compliance while coordinating trial registrations and results postings.

Ideal candidates bring 10+ years in regulatory labeling or disclosures, with strong MS Office skills and cross-functional collaboration experience. This is a hybrid US-based role with competitive compensation.