Associate Director, Regulatory Labeling and Disclosures

Why Sarepta?

Sarepta is at the forefront of genetic medicine, holding a leadership position in Duchenne muscular dystrophy (Duchenne) and building a robust portfolio across muscle, central nervous system, and cardiac diseases. In 2023, Sarepta launched its fourth therapy and the first-ever gene therapy to treat Duchenne. We seek individuals who see unlimited potential in themselves and are motivated by an unwavering commitment to patients.

What Sarepta Offers

Sarepta is committed to supporting employees in all aspects of their lives, fostering a culture where people bring their whole selves to work. We offer a range of benefits and work-life resources, including:

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

For a full list of comprehensive benefits, visit our website.

About the Role

The Associate Director, Regulatory Labeling and Disclosures, will lead global labeling activities for development and/or marketed products and manage disclosure activities for applicable clinical trials. This role involves developing, maintaining, and harmonizing core labeling (e.g., CCDS) and local labeling while ensuring compliance with regulatory requirements and supporting business objectives. The Associate Director may also oversee clinical trial registration, maintenance, and results posting on global Health Authority-managed databases (e.g., Clinicaltrials.gov, EudraCT).

Responsibilities

• Leads cross-functional labeling teams to develop and maintain US Full Prescribing Information, associated local labeling documents, Company Core Data Sheets (CCDS), and Target Product Labeling (TPL) for marketed and development products.
• Contributes to global labeling strategy and assists international regulatory colleagues in developing local or regional labeling consistent with reference labeling.
• Offers creative and compliant solutions aligned with business goals while ensuring regulatory integrity and consistency.
• Ensures alignment between reference labeling and regional adaptations while supporting affiliate needs.
• Collaborates with cross-functional leads on package labeling (artwork) development, updates, and maintenance.
• Supports Global Regulatory Strategists with Health Authority interactions, including submissions, responses to questions, and negotiations.
• May lead or support clinical trial registration, redactions, maintenance, and results posting to databases like Clinicaltrials.gov, EU CTIS, and similar platforms worldwide.
• Manages the process for individual participant data (IPD) report generation at the end of clinical studies and acts as the point of contact for external IPD requests.
• Builds and maintains relationships with the Global Regulatory Affairs team, cross-functional contributors, and external vendors to ensure compliance, accuracy, and completeness in clinical trial disclosure and transparency.
• Involved in developing, modifying, and executing company policies that affect operations.
• Ensures documentation management and record-keeping comply with regulatory expectations and Sarepta SOPs.
• Maintains knowledge of evolving regulations and guidance.
• Serves as a key contributor within Global Regulatory Teams to establish and implement regulatory strategy.
• Interacts across levels and functions to lead teams through successful engagements with Health Authorities.

Requirements

• BS in a related field with 10+ years of relevant experience; strong scientific education preferred.
• Experience in Regulatory Labeling (e.g., developing core and local labeling, label negotiations with Health Authorities) and/or Disclosures (e.g., publishing clinical trial registrations and results).
• Proficiency with Microsoft Office Applications (Word, Excel, Outlook) and regulatory systems.

Pay

The targeted salary range for this position is $160,800 - $201,000 per year. The salary offer considers factors including education, training, experience, external market conditions, criticality of role, and internal equity.

Schedule

This position requires work on-site at one of Sarepta’s facilities in the United States.