Senior Manager Regulatory Affairs US Advertising and Promotion

Senior Manager position overseeing US advertising and promotion regulatory compliance at AbbVie. Manages regulatory staff, monitors policy changes, and ensures pharmaceutical promotional materials meet FDA and internal standards across multiple office locations with hybrid scheduling.

Responsibilities

• Monitor government and industry activities affecting pharmaceutical regulatory policies; disseminate findings to stakeholders
• Oversee regulatory staff ensuring advertising and promotion materials comply with regulations and internal policies
• Develop and implement promotional activity strategies across therapeutic areas
• Manage direct reports and mentor staff on regulatory compliance and promotional guidelines
• Build relationships with cross-functional teams including Marketing, Medical, Legal, and Sales Training

Requirements

• Bachelor's degree in science or PharmD with 5-7 years relevant regulatory affairs experience
• Demonstrated experience in US regulatory affairs advertising and promotion
• Management experience and ability to supervise regulatory professionals
• Strong written and oral communication skills
• Negotiation skills and experience in complex matrix environments
• Knowledge of FDA regulations, CFR, PhRMA Guiding Principles, and promotional guidelines