Remote Associate Director, Regulatory Labeling & Disclosures

Sarepta Therapeutics; New Jersey; Hybrid; USD 161,000 - 201,000; Full time

Job summary

Sarepta Therapeutics seeks an Associate Director of Regulatory Labeling and Disclosures to lead global labeling activities for development and marketed products and to manage disclosure activities for clinical trials. This US remote-based role requires collaboration with internal stakeholders and external partners to ensure regulatory compliance and timeliness.

The position is hybrid, with options to work on-site at Sarepta facilities in the United States and occasional in-person events.

Qualifications

• Bachelor-level science degree required with strong scientific background.
• 10+ years of related regulatory labeling and/or disclosures experience preferred.
• Proficiency with Microsoft Office and regulatory systems required.

Responsibilities

• Lead global labeling activities for development and marketed products (US focus).
• Oversee clinical trial registration and results postings in Health Authority databases.
• Collaborate with cross-functional teams and external partners to ensure compliance.
• Develop and harmonize core labeling (CCDS) and local labeling documents.
• Support labeling strategy and HA interactions, including submissions and responses.

Skills

Regulatory labeling

Disclosures experience

MS Office

Education

BS in related field

Tools

Microsoft Office Suite

Regulatory systems

Job description

Sarepta Therapeutics seeks an Associate Director of Regulatory Labeling and Disclosures to lead global labeling activities for development and marketed products and to manage disclosure activities for clinical trials. This US remote-based role requires collaboration with internal stakeholders and external partners to ensure regulatory compliance and timeliness.

The position is hybrid, with options to work on-site at Sarepta facilities in the United States and occasional in-person events.