Associate Director, Regulatory Labeling and Disclosures

Sarepta Therapeutics; North Carolina; Hybrid; USD 161,000 - 201,000; Full time

Job summary

Sarepta Therapeutics is seeking an Associate Director of Regulatory Labeling and Disclosures to lead global labeling activities for development and marketed products from a US remote/hybrid position. You will staff cross-functional teams to ensure compliant labeling and disclosures while aligning with Health Authorities.

You will collaborate with regulatory, clinical, and market access teams to drive strategic labeling initiatives, submissions, and IPD/disclosure processes across regions and

Qualifications

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

Responsibilities

• Leads cross-functional labeling teams to develop and maintain US Full Prescribing Information and CCDS and TPL for marketed and development products.
• Contributes to the formulation of global labeling strategy and assists international regulatory colleagues in development of local or regional labeling.
• Responsive to business goals offering creative and compliant solutions while ensuring regulatory integrity and consistency in communications and activities.
• 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 HA interaction labeling strategy, including submissions, responses to questions, and negotiations.
• May lead or support coordinating activities for clinical trial registration, including redactions of clinical trial documents, registration maintenance and results posting to clinicaltrials.gov, EU CTIS, and similar databases worldwide in compliance with procedures, and applicable regulations.
• Manage process for individual participant data (IPD) report generation at the end of clinical studies and act as point on external IPD requests received through Sarepta's privacy team.
• Building and maintaining relationships with the Global Regulatory Affairs team, cross functional contributors, and the external vendors to support effective, efficient communication and maintain clinical trial disclosure and transparency compliance, accuracy, and completeness.
• Involved in developing, modifying, and executing company policies that affect immediate operations and may also have company-wide effect.
• Ensures documentation management and record keeping are compliant with regulatory expectations and Sarepta SOPs.
• Maintains knowledge of relevant evolving regulation and guidance.
• Key contributor within Global Regulatory Teams to establish and implement regulatory strategy.
• Interacts across levels and line functions to lead team through successful engagements with Health Authorities.

Skills

Regulatory labeling experience

Cross-functional collaboration

MS Office proficiency

Education

Bachelor's degree in a related field

Tools

Word

Excel

Outlook

Job description

Why Sarepta? Why Now?

The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

What Sarepta Offers

At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

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

For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us

The Importance of the Role

The Associate Director of Regulatory Labeling and Disclosures is a US remote based position. You will be responsible for leading global labeling activities for development and/or marketed products, and leading disclosure activities for applicable clinical trials. The Associate Director is responsible for the development, maintenance, and harmonization of core labeling (e.g., CCDS) and local labeling, ensuring compliance with applicable regulatory requirements while supporting business and lifecycle objectives. The Associate Director may also oversee the end-to-end operations for clinical trial registration, maintenance and results posting on Health Authority-managed databases worldwide (e.g., Clinicaltrials.gov, EudraCT). The Associate Director is responsible for effectively partnering and engaging with internal (e.g., cross-functional study teams, senior management) and external key stakeholders (e.g., vendors, business partners) to ensure business needs and regulatory requirements are met, prioritized, and communicated.

The Opportunity to Make a Difference

Primary Responsibilities Include:

• Leads cross-functional labeling teams to develop and maintain US Full Prescribing Information and associated local labeling documents, Company Core Data Sheets (CCDS), and Target Product Labeling (TPL) for marketed and development products
• Contributes to the formulation of global labeling strategy and assists international regulatory colleagues in development of local or regional labeling consistent with reference labeling
• Responsive to business goals offering creative and compliant solutions while ensuring company regulatory integrity and consistency in communications and activities
• 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 HA interaction labeling strategy, including submissions, responses to questions, and negotiations.
• May lead or support coordinating activities for clinical trial registration, including redactions of clinical trial documents, registration maintenance and results posting to clinicaltrials.gov, EU CTIS, and similar databases worldwide in compliance with procedures, and applicable regulations
• Manage process for individual participant data (IPD) report generation at the end of clinical studies and act as point on external IPD requests received through Sarepta's privacy team
• Building and maintaining relationships with the Global Regulatory Affairs team, cross functional contributors, and the external vendors to support effective, efficient communication and maintain clinical trial disclosure and transparency compliance, accuracy, and completeness
• Involved in developing, modifying, and executing company policies that affect immediate operations and may also have company-wide effect
• Ensures documentation management and record keeping are compliant with regulatory expectations and Sarepta SOPs
• Maintains knowledge of relevant evolving regulation and guidance
• Key contributor within Global Regulatory Teams to establish and implement regulatory strategy
• Interacts across levels and line functions to lead team through successful engagements with Health Authorities

More about You

• BS in related field with 10+ years of related 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 applicable clinical trial registrations and/or results), preferred
• Proficiency with Microsoft Office Applications; Word, Excel, Outlook, and regulatory systems.

What Now?

This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time. The targeted salary range for this position is $160,800 - $201,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. Candidates must be authorized to work in the U.S. Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.