Director, US Advertising and Promotion – Global Regulatory Affairs

• Make decisions and provide strategic direction and oversight for assigned products, departmental activities, and direct reports
• Develop effective regulatory strategies regarding product promotion with the US A&P Therapeutic Area Head
• Provide senior regulatory guidance and advice during issues management activities
• Monitor the regulatory environment and evaluate the business impact of new regulations, guidance documents, and enforcement trends
• Mentor and develop US A&P staff
• Establish internal relationships with Commercial, R&D, Communications, Compliance, and Legal teams
• Ensure alignment and consistency in US A&P policy application across assigned products
• Establish and maintain relationships with relevant FDA staff
• Develop and implement regulatory strategies for marketed products
• Provide input into global labeling strategies for marketed and pipeline products
• Liaise with FDA regarding product promotion matters
• Perform other duties as assigned

• Bachelor’s degree from an accredited four-year college or university;
  Science focus preferred, but not required
• Experience with in pharmaceutical or medical device Regulatory Affairs
• 8+ years relevant regulatory experience
• Experience in Advertising and Promotion in Regulatory required
• Experience dealing effectively with cross-functional groups, including Medical, Legal, and Marketing
• Extensive knowledge and understanding of complex medical and scientific subject matter
• Understanding of the U.S. pharmaceutical marketplace and familiarity with medical terminology
• Solid oral communication and writing skills
• Ability to work well within cross-functional teams
• Ability to manage product support projects
• Ability to establish priorities and timelines and multi-task effectively
• Unquestionable ethics, professional integrity, and personal values consistent with Sanofi values

Demonstrates extensive regulatory expertise in the pharmaceutical industry, particularly in Advertising and Promotion, while effectively managing cross-functional relationships and providing strategic oversight for product-related activities.

• Regulatory Affairs Experience
• Advertising And Promotion Expertise
• Cross-Functional Collaboration
• Strategic Direction And Oversight
• FDA Liaison Experience

• Regulatory Strategy Development
• Product Promotion Regulation
• Labeling Strategy Input
• Regulatory Environment Monitoring
• Complex Medical Subject Matter Understanding

• Solid Oral Communication
• Writing Skills
• Project Management
• Prioritization And Multi-Tasking
• Mentoring And Development

• Pharmaceutical Industry
• Medical Device Regulatory Affairs
• U.S. Pharmaceutical Marketplace
• Compliance
• Sanofi Values