Associate Director, Regulatory Affairs Advertising & Promotion

Role Summary

The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary teams, and executing multidivisional initiatives. Develops and leverages broad industry knowledge to anticipate future trends and identify cross-organizational opportunities.

Responsibilities

• Make decisions and plans for operations within area of responsibility with minimal direction. Set strategy and lead cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives.
• Maintain and evaluate productivity metrics to project current and future business needs.
• Align and maintain effective communication with Medical, Marketing, Regulatory, Legal, and Public Affairs counterparts. Identify areas for process/policy improvement, develop recommendations/plan, and lead initiatives.
• Assist in managing the departmental budget; identify and communicate budgetary needs to Operations and Finance; project current and future expenditures and business needs.
• Collect and analyze issues/trends affecting the business to identify cross-organization opportunities; apply knowledge of global marketplace, technology, and business levels.
• Operate independently, recognizing when to consult senior leadership on risks. In the absence of the Director, oversee day-to-day operations and departmental initiatives with significant impact on internal and external customers.
• Encourage innovation and hold employees accountable for delivering goals; mentor, recognize, reward, and recommend promotion based on performance, results, and development.
• Demonstrate solid understanding of regulations and guidance from regulatory authorities, political and legal climate, and industry practices related to advertising and promotions.
• Develop and implement complex processes and projects; deliver strategic presentations for senior management.
• Identify areas for process improvement and lead related initiatives.

Qualifications

• Bachelor‚Äôs Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, nursing)
• Relevant Master‚Äôs or Ph.D., or advanced scientific or law degree preferred
• Certification a plus
• 8 years of industry-related experience preferred; 8 years in pharmaceutical experience with emphasis on RA strategy or US Advertising and Promotion preferred
• Experience in a complex and matrix environment
• Strong oral and written communication skills
• Experience developing and implementing successful global regulatory strategies
• Experience in a management capacity preferred

Skills

• Regulatory strategy for advertising and promotion
• Cross-functional leadership and team management
• Stakeholder communications and collaboration
• Budgeting and financial planning
• Analytical reasoning and trend analysis
• Strategic presentation and senior management briefing

Education

• As listed in Qualifications

Additional Requirements

• The preferred location is Mettawa, IL (hybrid); remote work may be considered for non-local candidates.