Senior Regulatory Labeling & Disclosures Lead (Remote)

Sarepta Therapeutics; Newark (NJ); 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 and clinical trial disclosures. You will collaborate with cross-functional teams and Health Authorities to ensure compliant labeling and transparency.

Role is US remote-based with hybrid on-site expectations at Sarepta facilities. A BS plus 10+ years in regulatory labeling and MS Office proficiency are required, with competitive compensation and benefits.

Qualifications

• Experience in Regulatory Labeling (e.g., core and local labeling) and/or Disclosures (clinical trial registrations and results).
• Proficiency with Microsoft Office Applications; Word, Excel, Outlook, and regulatory systems.

Responsibilities

• Leads cross-functional labeling teams to develop US Full Prescribing Information and CCDS/TPL for products.
• Contributes to global labeling strategy and regional labeling alignment.
• Ensures regulatory integrity and compliant communications while supporting business goals.
• Ensures alignment between reference labeling and regional adaptations; supports affiliate needs.
• Collaborates on package labeling development, updates, and maintenance.
• Supports HA interactions labeling strategy including submissions and responses.

Skills

MS Office

Regulatory systems

Education

BS in related field

Job description

Sarepta Therapeutics seeks an Associate Director of Regulatory Labeling and Disclosures to lead global labeling activities and clinical trial disclosures. You will collaborate with cross-functional teams and Health Authorities to ensure compliant labeling and transparency.

Role is US remote-based with hybrid on-site expectations at Sarepta facilities. A BS plus 10+ years in regulatory labeling and MS Office proficiency are required, with competitive compensation and benefits.