Sr. Director, US Advertising & Promotion, Regulatory Affairs

Your Role

You will lead the US Advertising and Promotion organization, working closely with US legal and medical teams to drive the promotional review process, ensure regulatory compliance, and support key business objectives. You will be recognized as a knowledgeable resource for commercial regulatory advice across promotional, corporate, and other non-promotional initiatives. In this role, you will collaborate with management on resource planning and implementation, while leading complex regional projects that require big-picture strategic thinking and effective problem-solving.

Your 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.

Your Qualifications

• 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 includes understanding of how RA contribute to the drug development process including life-cycle management.

Your New Team

You will join a highly collaborative environment, working closely with leaders across Global Regulatory Affairs and key US business functions—including legal, marketing, market access, and medical. This role partners with stakeholders at all management levels to ensure aligned, high-quality regulatory and promotional outcomes.

Compensation

The base salary range for this position is $225,000 - $305,000 per year. The base salary range represents the anticipated low and high of the LEO Pharma range for this position. Salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. In addition, some positions may include eligibility to earn commissions/bonus based on company and/or individual performance.