Lead, Global Regulatory Labeling & Disclosures — Remote

Sarepta Therapeutics; North Carolina; Hybrid; USD 161,000 - 201,000; Full time

Job summary

Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures to lead global labeling activities for development and marketed products from a US remote/hybrid position. You will staff cross-functional teams to ensure compliant labeling and disclosures while aligning with Health Authorities.

You will collaborate with regulatory, clinical, and market access teams to drive strategic labeling initiatives, submissions, and IPD/disclosure processes across regions and

Qualifications

• BS in related field with 10+ years of related experience.
• Experience in Regulatory Labeling and/or Disclosures.
• 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 and CCDS and TPL for marketed and development products.
• Contributes to the formulation of global labeling strategy and assists international regulatory colleagues in development of local or regional labeling.
• Responsive to business goals offering creative and compliant solutions while ensuring regulatory integrity and consistency in communications and activities.
• Ensures alignment between reference labeling and regional adaptations while supporting affiliate needs.
• Collaborates with cross-functional leads on package labeling (artwork) development, updates, and maintenance.
• Supports Global Regulatory Strategists with HA interaction labeling strategy, including submissions, responses to questions, and negotiations.
• May lead or support coordinating activities for clinical trial registration, including redactions of clinical trial documents, registration maintenance and results posting to clinicaltrials.gov, EU CTIS, and similar databases worldwide in compliance with procedures, and applicable regulations.
• Manage process for individual participant data (IPD) report generation at the end of clinical studies and act as point on external IPD requests received through Sarepta's privacy team.
• Building and maintaining relationships with the Global Regulatory Affairs team, cross functional contributors, and the external vendors to support effective, efficient communication and maintain clinical trial disclosure and transparency compliance, accuracy, and completeness.
• Involved in developing, modifying, and executing company policies that affect immediate operations and may also have company-wide effect.
• Ensures documentation management and record keeping are compliant with regulatory expectations and Sarepta SOPs.
• Maintains knowledge of relevant evolving regulation and guidance.
• Key contributor within Global Regulatory Teams to establish and implement regulatory strategy.
• Interacts across levels and line functions to lead team through successful engagements with Health Authorities.

Skills

Regulatory labeling experience

Cross-functional collaboration

MS Office proficiency

Education

Bachelor's degree in a related field

Tools

Word

Excel

Outlook

Job description

Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures to lead global labeling activities for development and marketed products from a US remote/hybrid position. You will staff cross-functional teams to ensure compliant labeling and disclosures while aligning with Health Authorities.

You will collaborate with regulatory, clinical, and market access teams to drive strategic labeling initiatives, submissions, and IPD/disclosure processes across regions and