Senior Director, Ad Promo

Role Summary

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.

Responsibilities

• Oversees and provides strategic regulatory advice for the development and approval of compliant advertising and promotional materials across the product lifecycle—including development-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 SOPs 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

Qualifications

• 15+ years of related experience
• Prior regulatory affairs experience in major markets (FDA or EU) is expected

Skills

• Extensive experience in Regulatory Promotional review
• Strong leader with demonstrated management of contract or permanent staff; experience managing remote and local employees and/or regulatory consultancies
• Excellent interpersonal, collaboration, written, verbal and visual communication skills with ability to influence cross-functionally
• Exceptional ability to interpret and apply regulatory requirements to real-world promotional tactics
• Strong analytical skills, problem solving, and strategic thinking; detail-oriented while analyzing the big picture
• Ability to exercise sound judgment in fast-moving, high-visibility situations
• Goal-oriented, results-focused, and flexible; proven ability to manage projects and timelines, organize/track complex information, prioritize, and adapt to shifting priorities
• Collaborates effectively with cross-functional colleagues at all levels
• Ability to evaluate and recommend process improvements; ability to suggest and implement best practices
• Solid sense of accountability and sound judgement; high ethical standards and focus on quality and attention to detail
• Experience communicating with stakeholders/partners at all levels globally
• Proficiency with Microsoft Office Applications; Word, Excel, Outlook, and regulatory systems

Education

• BS or equivalent

Additional Requirements

• Hybrid on-site requirement at a Sarepta facility in the United States and occasional attendance at Company-sponsored in-person events
• Candidates must be authorized to work in the U.S.