Associate Director, Labeling and Disclosures
$160,800–$201,000 year
On-siteCambridge, Massachusetts, United States
Job Summary
Lead global labeling activities for development and marketed products, including the development, maintenance, and harmonization of core labeling (CCDS) and local documents to ensure regulatory compliance. Manage end-to-end operations for clinical trial registration and results posting on Health Authority-managed databases worldwide, coordinating with internal teams and external vendors to maintain disclosure transparency. Formulate global labeling strategy, collaborate on package labeling artwork, and oversee individual participant data report generation while ensuring alignment between reference and regional adaptations. This role requires a BS in a related field with 10+ years of experience in regulatory labeling and disclosures. The position is onsite at a Sarepta facility in the U.S. with a salary range of $160,800 - $201,000.
Required Qualifications
- BS in related field
- 10+ years of related experience
- Candidates must be authorized to work in the U.S.
- This position requires work on site at one of Sarepta's facilities in the United States
Desired Qualifications
- Experience in Regulatory Labeling (e.g., developing core and local labeling, label negotiations with Health Authorities)
- Experience in Disclosures (e.g., publishing applicable clinical trial registrations and/or results)
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