Senior Director, Ad Promo

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 Senior Director of Regulatory Advertising & Promotion serves as the strategic regulatory leader for U.S. promotional activities across the product lifecycle—including development-stage assets, launch materials, and fully marketed products (including Accelerated Approved products). This role provides expert guidance to ensure that all promotional, disease‑state, and external‑facing communications comply with FDA regulations and industry standards while supporting business objectives. The Senior Director partners closely with key stakeholders and senior leadership to shape compliant and competitive promotional strategies from pre‑launch planning through post‑market execution. This role also facilitates risk identification and mitigation strategies, as well as oversees regulatory interactions with OPDP/APLB. The Senior Director develops and maintains a Performance Culture through building and sustaining high performing teams responsible for the timely review, approval and submission of promotional content.

The Opportunity to Make a Difference

Principle Duties and Responsibilities

• Oversees and provides strategic regulatory advice and for the development and approval of compliant advertising and promotional materials across the product lifecycle- includingdevelopment-stage assets, launch materials, and fully marketed products (including Accelerated Approved products), disease state education, field training, external communications, and for non-promotional pre-approval communications
• Oversees the development of launch materials/new claim by collaborating with Marketing, Medical and Legal
• Responsive to business goals offering creative and compliant solutions while ensuring Company regulatory integrity and consistency in communications and activities
• Develops and maintains working relationships with OPDP/APLB staff as necessary
• Represents RA on multidisciplinary teams to integrate company goals into regulatory objectives & activities
• Global Regulatory Teams – key contributor to establish and implement regulatory strategy
• Maintains a deep knowledge of FDA enforcement trends and relevant evolving regulation and guidance, and advises appropriate departments within the company of these requirements
• Identifies and spearheads training in FDA regulations for pharmaceutical advertising and promotion, as well as FDA enforcement trends, to Sarepta employees and/or its representatives
• Advises on the development and implementation of the strategic approach to building and maintaining an efficient and compliant MLR process
• Creates a strong regulatory promotional compliance infrastructure, which includes overseeing the development of SOP’s that support inspection-readiness
• Builds and maintains a strong working relationship with internal MLR stakeholders, including Marketing, Marketing Operations, Patient Affairs, Legal, Medical/Medical Affairs, and Scientific/Medical Communications
• Champions to stakeholders at all levels within the organization a collaborative, solution-oriented culture aligned with company goals

Impact and Scope

• Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company
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