Director, Labeling

Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. 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 Director of Regulatory Labeling will lead and facilitate the generation of new, and revision of, Core Labeling (Target Product Profile, Company Core Data Sheet) and Local Labeling documents (e.g., US Prescribing Information), in collaboration with cross-functional subject matter experts as well as external alliance partners. The qualified candidate will provide leadership in building and strengthening the regulatory labeling infrastructure and SOPs that support inspection readiness. They will serve as a key member of the Global Regulatory Team for development and marketed products, contributing to the development of company goals, and are responsible for integrating these goals into global labeling activities.

The Opportunity to Make a Difference

• Develop and enhance labeling processes and procedures including those governing global Target Product Profile, Company Core Data Sheets, Company Core Safety Information (CCSI), and local or regional labeling to assure efficient and time creation and management of all labeling documents.
• Formulate and direct implementation of global labeling strategy in line with company goals
• Lead cross-functional labeling teams for development, review, approval, maintenance and execution of core and local labeling.  Guide international regulatory colleagues for development of international local or regional labeling.
• Work with the Regulatory strategist on relevant Product Teams to enhance product development and assure that labeling objectives are identified, understood and supported by the programs.
• Assure that labeling documents are submission-ready and compliant with applicable laws and regulations.
• Be responsive to business goals offering creative and compliant solutions while ensuring Company regulatory integrity and consistency in communications and activities 
• Provide analysis of competitor labeling in the relevant therapeutic area 
• Actively participate on project teams and regulatory sub-teams, as appropriate 
• Identify and alerts GRA leadership to the need for potential risk mitigation discussions
• Maintain current knowledge and understanding of applicable State and Federal laws, regulations and policies related to labeling of pharmaceuticals and advises appropriate departments within the company of these requirements
• Participate in developing, modifying, and executing company policies that affect immediate operations and may also have company-wide effect. Provides input to enhance policies, standard operating procedures, best practices, and work instructions.
• Contribute to expansion of the regulatory labeling staff, as needed. May oversee activities of junior regulatory personnel and manage contractual and budgetary responsibilities with best business practices.

More about You

• BS or equivalent with 12+ years of related experience
• Prior experience in labeling content development and maintenance required
• Prior experience in rare disease and accelerated approval products preferred.
• Experience working with and leading cross-functional teams.
• Working understanding of registration dossiers