Senior Director, Ad Promo

Sarepta Therapeutics•Cambridge, MA

1d•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

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
Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company
Oversees execution of tasks, involved in mentoring and goal/strategy setting
Provides strategic guidance on projects that have critical impact on functional area and organization
Typically develops organizational policies and authorizes their implementation.
Champions alignment with organizational business objectives both within GRA and cross-functionally
Serve as a trusted advisor to senior leadership, helping balance business needs with regulatory risk.
Prior involvement with digital and social media promotional strategies.
Expected to present and contribute to presentations at governance committees including Research and development Committee, the Executive Committee, and the Communications Committee