Remote Associate Director, Regulatory Labeling Disclosures

Sarepta Therapeutics; Town of Texas (WI); Hybrid; USD 161,000 - 201,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Job summary

Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures for a US remote-based role with hybrid expectations. You will lead global labeling activities and disclosures while ensuring regulatory compliance, partnering with cross-functional teams, and overseeing external vendors to support lifecycle objectives.

The role emphasizes building CCDS and core labeling, aligning regional labeling with reference labeling, and coordinating submissions, responses, and

Qualifications

• BS in related field with 10+ years of experience in regulatory labeling and disclosures.
• Experience in Regulatory Labeling and/or Disclosures preferred.
• Proficiency with Word, Excel, Outlook and regulatory systems.

Responsibilities

• Lead cross-functional labeling teams to develop and maintain US Full Prescribing Information and CCDS.
• Contribute to global labeling strategy and regional labeling harmonization.
• Ensure regulatory integrity and timely communications across functions.
• Coordinate labeling updates for artwork, packaging, and disclosures.
• Support clinical trial registration and results postings in public databases.

Skills

Regulatory labeling experience

Regulatory systems

Cross-functional collaboration

Microsoft Office

Education

BS in related field

Tools

Regulatory systems

Job description

Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures for a US remote-based role with hybrid expectations. You will lead global labeling activities and disclosures while ensuring regulatory compliance, partnering with cross-functional teams, and overseeing external vendors to support lifecycle objectives.

The role emphasizes building CCDS and core labeling, aligning regional labeling with reference labeling, and coordinating submissions, responses, and