Regulatory Advertising & Promotions Director

This company is a leader in pain management and related diseases. They are seeking a Regulatory Affairs Advertising & Promotion Director who can develop and execute regulatory strategies for all advertising and promotional activities in the United States. This individual will provide strategic regulatory guidance to US commercial teams, offering risk-based recommendations to support the planning and execution of marketing initiatives.

This company offers a collaborative, patient-focused, and entrepreneurial culture, along with flexible work arrangements. With two approved products and new programs going into clinical trials, now is an exciting time to join this company!

• Serve as the primary expert on FDA requirements for the review of promotional, disease-state, and scientific exchange materials, ensuring all communications comply with applicable regulations.
• Lead and manage the US Materials Review processes, ensuring robust procedures for the creation, review, and approval of promotional, non-promotional, scientific exchange, and external communications that meet all regulatory requirements and support operational excellence.
• Ensure compliant review and approval of all professional and direct-to-consumer promotional and non-promotional materials for approved US products.
• Oversee review of materials for investigational products, ensuring all US-facing materials adhere to FDA regulations and avoid any implication of pre-approval promotion.
• Build strong partnerships and collaborate effectively with cross-functional Medical, Legal, and other LMR team members to enable timely, aligned decision-making.
• Serve as the Subject Matter Expert on FDA advertising and promotion regulations, providing strategic guidance on promotional concepts, launch strategies, branding, campaigns, and materials for both approved and investigational products.
• Collaborate with Global Regulatory Affairs to ensure US promotional and sales training materials reflect current US prescribing information and align with global product strategy where appropriate.
• Act as the primary liaison to FDA’s Office of Prescription Drug Promotion (OPDP), including oversight of FDA Form 2253 submissions for assigned products.
• Ensure that cross-functional advertising and promotion review teams operate effectively, follow established processes, and drive timely, compliant decision-making.
• Oversee regulatory contractor(s) responsible for coordinating the review and approval of promotional and non-promotional materials.
• Advise US Commercial teams on regulatory requirements and risk-based best practices to support compliant planning and execution of marketing strategies.
• Provide input to US teams on the development of US prescribing information and carton/container labeling from an AdPromo perspective.
• Ensure consistent application of regulatory standards across US Materials Review teams and verify adherence to established processes, documentation practices, and governance expectations.
• Represent US Commercial Regulatory in relevant cross-functional initiatives, including committees, training programs, and due diligence activities.
• Lead additional regulatory activities as assigned beyond advertising and promotion, contributing to broader regulatory initiatives as needed.

• Bachelor’s degree in scientific discipline; advanced degree (MS, PhD, PharmD) preferred.
• A minimum of 7 years of Regulatory Affairs experience with a focus on US regulatory affairs, including advertising and promotional regulations.
• Experience reviewing promotional materials across a variety of platforms (print, online, broadcast, and social)
• Experience reviewing payer, provider and consumer materials.
• Direct experience engaging with FDA, preferably including interactions with the Office of Prescription Drug Promotion (OPDP).
• Experience Developing and executing innovative regulatory strategies, assessing & communicating risk/benefit to senior management, and influencing organizational direction.
• Some experience with Labeling development and life-cycle management desired but not required.
• Extensive knowledge of US regulatory environment including FDA regulations, guidance documents, enforcement trends, and best practices related to advertising, promotion, and scientific exchange.
• Experience participating in or leading cross-functional materials review committees (LMR).
• Strong understanding of the competitive landscape, with the ability to monitor regulatory and promotional trends and translate…