Responsibilities

• Provide management, leadership, and development for the team overseeing US Advertising and Promotion strategy and operations to ensure compliance while supporting US business objectives.
• Lead best practices for assessing promotional materials for completeness, accuracy, and compliance with OPDP requirements.
• Serve as the internal expert on FDA regulations, guidance, and enforcement trends governing prescription drug promotion, and act as the primary contact with FDA’s Office of Prescription Drug Promotion (OPDP), ensuring timely submissions.
• Develop and implement policies, SOPs, and strategic oversight for promotional and non‑promotional reviews, targeting key operational components for execution.
• Serve as the senior regulatory representative on the US Legal, Medical, and Regulatory (LMR) team and define the department’s mission, vision, service deliverables, goals, and customer focus.
• Ensure compliance with the LEO Code of Conduct and QMS while building strategic regulatory, project management, process management, and knowledge‑sharing capabilities.
• Chair or participate in cross‑functional and cross‑company steering committees for regulatory business processes, systems, organizational initiatives, and compliance projects.
• Act as a leader internally and externally, contributing to cross‑functional initiatives, influencing the field, and mobilizing organizational change across the department.
• Oversee project team deliverables to scope, time, and budget, and complete all required company‑based and job‑related training.

Requirements

• Master’s degree within science, e.g. pharmaceutics, biomedicine, engineering
• Minimum 8 years of experience working within regulatory advertising and promotion and 3+ years of managerial and leadership experience
• Solid experience working within the Regulatory Affairs area and with interfacing functions
• Deep understanding of the regulatory pharmaceutical framework and procedures globally is a must. This include understanding of how RA contribute to the drug development process including life-cycle management