Senior Regulatory Labeling & Disclosures Lead - Remote

Sarepta Therapeutics; California; Remote; USD 161,000 - 201,000; Full time

Benefits offered by this job

Comprehensive benefits

Job summary

Sarepta Therapeutics is seeking a qualified candidate for the role of Associate Director of Regulatory Labeling and Disclosures. This US-remote based position leads global labeling activities, manages disclosures for clinical trials, and ensures compliance with regulatory requirements while supporting lifecycle objectives.

Required: BS in a related field with 10+ years of experience in Regulatory Labeling and/or Disclosures, and proficiency with Microsoft Office applications.

Qualifications

• Experience in Regulatory Labeling and/or Disclosures preferred.
• Strong proficiency with Microsoft Word, Excel, Outlook and regulatory systems.
• Excellent collaboration with cross-functional teams and external partners.

Responsibilities

• Leads cross-functional labeling teams to develop and maintain US Full Prescribing Information, CCDS, and TPL for products.
• Contributes to global labeling strategy and aligns local labeling with reference labeling.
• Supports clinical trial registration and results posting on Health Authority databases.
• Manages IPD reporting process and external IPD requests.
• Ensures regulatory documentation and disclosures meet regulatory expectations and Sarepta SOPs.
• Collaborates with Global Regulatory Affairs and external vendors to support labeling and disclosure activities.

Skills

Regulatory labeling

Disclosures

Microsoft Office

Education

BS in related field

Job description

Sarepta Therapeutics is seeking a qualified candidate for the role of Associate Director of Regulatory Labeling and Disclosures. This US-remote based position leads global labeling activities, manages disclosures for clinical trials, and ensures compliance with regulatory requirements while supporting lifecycle objectives.

Required: BS in a related field with 10+ years of experience in Regulatory Labeling and/or Disclosures, and proficiency with Microsoft Office applications.