Senior Director, Ad Promo

Sarepta Therapeutics • Cambridge, MA

12d • Hybrid

About The Position

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.

Requirements

• 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; must be able to remain detail-oriented while analyzing the big picture
• Ability to exercise sound judgment in fast‑moving, high‑visibility situations.
• Must be goal-oriented, results-focused, and flexible; proven ability to successfully manage projects and timelines, organize/track complex information, prioritize accordingly, and the ability to quickly adjust to shifting priorities and demanding timelines when necessary
• Collaborates effectively with cross-functional colleagues at all levels
• Ability to evaluate and recommend process improvement; ability to suggest and implement best practices
• Solid sense of accountability and sound judgement; highest ethical standards and focus on quality and attention to detail
• Experience working with and effectively communicating to stakeholders/partners at all levels, globally, across the organization
• Proficiency with Microsoft Office Applications; Word, Excel, Outlook, and regulatory systems
• BS or equivalent with 15+ years of related experience
• Prior regulatory affairs experience in major markets (FDA or EU) is expected
• Candidates must be authorized to work in the U.S.

Nice To Haves

• Prior involvement with digital and social media promotional strategies.

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

Benefits

• 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
• Sarepta Therapeutics offers a competitive compensation and benefit package.

What This Job Offers

• Job Type: Full-time
• Career Level: Director