Associate Director, Regulatory Labeling and Disclosures
Sarepta Therapeutics
August 30, 2026
On-site
United States
Corporate Functions
The Associate Director, Labeling and Disclosures, will lead global labeling activities for development and/or marketed products and lead disclosure activities for applicable clinical trials.
Primary Responsibilities:
- Lead cross-functional labeling teams to develop and maintain US Full Prescribing Information, local labeling documents, Company Core Data Sheets (CCDS), and Target Product Labeling (TPL).
- Contribute to global labeling strategy; assist international colleagues with local/regional labeling consistent with reference labeling.
- Provide creative, compliant solutions aligned with business goals while ensuring regulatory integrity.
- Ensure alignment between reference labeling and regional adaptations; support affiliate needs.
- Collaborate on package labeling (artwork) development, updates, and maintenance.
- Support Health Authority (HA) interaction labeling strategy, including submissions, responses to questions, and negotiations.
- Coordinate clinical trial registration activities, including redactions, registration maintenance, and results posting (Clinicaltrials.gov, EU CTIS, and similar databases).
- Manage individual participant data (IPD) report generation and act as point for external IPD requests via the privacy team.
- Build and maintain relationships with Global Regulatory Affairs and external vendors; ensure clinical trial disclosure/transparency compliance.
- Develop/execute policies impacting operations; ensure documentation management and record keeping per regulations and SOPs.
- Maintain knowledge of evolving regulations/guidance; contribute to regulatory strategy and lead Health Authority engagements.
Qualifications:
- BS in related field with 10+ years of related experience.
- Experience in Regulatory Labeling and/or Disclosures (preferred).
- Proficiency with Microsoft Office (Word, Excel, Outlook) and regulatory systems.
Application instructions:
- Apply if you are solution-oriented and able to work with ambiguity.
Work/eligibility:
- On-site at a US facility; must be authorized to work in the US.
Primary Responsibilities:
- Lead cross-functional labeling teams to develop and maintain US Full Prescribing Information, local labeling documents, Company Core Data Sheets (CCDS), and Target Product Labeling (TPL).
- Contribute to global labeling strategy; assist international colleagues with local/regional labeling consistent with reference labeling.
- Provide creative, compliant solutions aligned with business goals while ensuring regulatory integrity.
- Ensure alignment between reference labeling and regional adaptations; support affiliate needs.
- Collaborate on package labeling (artwork) development, updates, and maintenance.
- Support Health Authority (HA) interaction labeling strategy, including submissions, responses to questions, and negotiations.
- Coordinate clinical trial registration activities, including redactions, registration maintenance, and results posting (Clinicaltrials.gov, EU CTIS, and similar databases).
- Manage individual participant data (IPD) report generation and act as point for external IPD requests via the privacy team.
- Build and maintain relationships with Global Regulatory Affairs and external vendors; ensure clinical trial disclosure/transparency compliance.
- Develop/execute policies impacting operations; ensure documentation management and record keeping per regulations and SOPs.
- Maintain knowledge of evolving regulations/guidance; contribute to regulatory strategy and lead Health Authority engagements.
Qualifications:
- BS in related field with 10+ years of related experience.
- Experience in Regulatory Labeling and/or Disclosures (preferred).
- Proficiency with Microsoft Office (Word, Excel, Outlook) and regulatory systems.
Application instructions:
- Apply if you are solution-oriented and able to work with ambiguity.
Work/eligibility:
- On-site at a US facility; must be authorized to work in the US.