Senior Regulatory Labeling & Disclosures Leader (Remote)

Sarepta Therapeutics; Connecticut; 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 and disclosure efforts for development and marketed products. This US remote-based role requires collaboration with cross-functional teams and external partners to ensure regulatory compliance and timely submissions.

The position emphasizes building robust labeling strategies, managing IPD data requests, and ensuring transparency across clinical trial disclosures, with

Qualifications

• Experience in regulatory labeling and/or disclosures is preferred.
• Proficiency with Microsoft Office applications including Word, Excel, Outlook.

Responsibilities

• Lead cross-functional labeling teams to develop US Full Prescribing Information and CCDS.
• Oversee global labeling strategy and local labeling harmonization.
• Support clinical trial registration and results postings in Health Authority databases.

Skills

Regulatory labeling

Disclosures experience

MS Office proficiency

Education

BS 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 and disclosure efforts for development and marketed products. This US remote-based role requires collaboration with cross-functional teams and external partners to ensure regulatory compliance and timely submissions.

The position emphasizes building robust labeling strategies, managing IPD data requests, and ensuring transparency across clinical trial disclosures, with