Remote Global Regulatory Labeling & Disclosure Lead

Sarepta Therapeutics; Rhode Island; Hybrid; USD 161.000 - 201.000; Vollzeit

Zusammenfassung

Sarepta Therapeutics seeks an experienced leader for Regulatory Labeling and Disclosures. The role leads global labeling activities, develops core data sheets, and guides regulatory strategy across development and marketed products.

You will engage with Health Authorities and cross-functional teams to ensure compliant labeling and disclosures. The position is hybrid, US-based with potential in-person duties; strong scientific background and 10+ years in regulatory labeling are required, with

Qualifikationen

• BS in related field with 10+ years of regulatory labeling or disclosures experience.
• Experience in Regulatory Labeling and/or Disclosures with Health Authority interactions.
• Proficiency with Microsoft Office Applications; Word, Excel, Outlook, and regulatory systems.

Aufgaben

• Leads cross-functional labeling teams to develop and maintain US Full Prescribing Information and CCDS, and local labeling documents.
• Contributes to global labeling strategy and alignment with regional labeling.
• Ensures regulatory integrity and consistency in communications and activities.
• Oversees clinical trial registration, maintenance and results postings on public databases.
• Manages IPD reporting and external IPD requests with Sarepta privacy.
• Builds relationships with Global Regulatory Affairs, cross-functional teams, and vendors.
• Interacts with Health Authorities to lead regulatory strategy.

Kenntnisse

Regulatory labeling experience

Regulatory systems proficiency

Cross-functional collaboration

Ausbildung

BS in related field

Tools

Microsoft Office

Jobbeschreibung

Sarepta Therapeutics seeks an experienced leader for Regulatory Labeling and Disclosures. The role leads global labeling activities, develops core data sheets, and guides regulatory strategy across development and marketed products.

You will engage with Health Authorities and cross-functional teams to ensure compliant labeling and disclosures. The position is hybrid, US-based with potential in-person duties; strong scientific background and 10+ years in regulatory labeling are required, with