Remote Assoc Dir, Regulatory Labeling & Disclosures

Sarepta Therapeutics; Town of Florida (NY); Hybrid; USD 160,000 - 201,000; Full time

Job summary

Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures to lead US and global labeling efforts from a remote-based position in the US. The role emphasizes development, maintenance, and harmonization of core labeling and CCDS, with oversight of trials disclosures and regulatory submissions.

The ideal candidate brings a strong background in regulatory labeling, cross-functional teamwork, and experience with Health Authority interactions within a hybrid work

Qualifications

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

Responsibilities

• Leads cross-functional labeling teams to develop US Full Prescribing Information and CCDS.
• Manages local labeling and Target Product Labeling for products.
• Supports labeling strategy and international regional labeling alignment.
• Oversees regulatory submissions, health authority interactions, and disclosures.
• Coordinates IPD and clinical trial disclosure activities as applicable.

Skills

Regulatory labeling

Disclosures (clinical trials)

Cross-functional collaboration

MS Office (Word, Excel, Outlook)

Health Authority interactions

Education

BS in related field

Tools

Regulatory systems

Job description

Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures to lead US and global labeling efforts from a remote-based position in the US. The role emphasizes development, maintenance, and harmonization of core labeling and CCDS, with oversight of trials disclosures and regulatory submissions.

The ideal candidate brings a strong background in regulatory labeling, cross-functional teamwork, and experience with Health Authority interactions within a hybrid work