Director, Regulatory Affairs Advertising & Promotion

Summary

Join AbbVie as a Director of Regulatory Affairs, US Advertising and Promotion and be responsible for implementing regulatory advertising and promotion strategies for marketed and development compounds. You will contribute to strategic planning, manage projects, and develop individual and team performance. The role involves advising cross-functional teams, ensuring compliance with company processes, providing regulatory guidance, and conducting reviews of advertising and promotional materials. You will lead cross-functional teams, possess strong knowledge of DDMAC guidance, and make sound regulatory decisions. Collaboration with other departments, such as Regulatory Operations and the labeling group, is also expected.

Requirements

• Possess a Bachelor's Degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology)
• Possess 10 years of pharmaceutical experience , with 5 years direct advertising and promotion review experience
• Have a solid understanding of regulatory advertising and promotion regulations

Responsibilities

• Advise cross-functional teams on content and message consistency and best practices regarding planning and execution of marketing strategies
• Assure that cross-functional advertising and promotion review teams are operating according to approved company processes and procedures
• Be responsible for the training of regulatory staff, as required
• Provide regulatory guidance regarding advertising and promotional materials, new campaigns and launch strategies
• Conduct review and approval of professional and direct to consumer advertising and promotion and providing comments to review teams
• Effectively lead and establish strong working relationships with cross-functional review teams, both internal and with co-promotional partners. Serves as leader of cross-functional promotion review team meetings
• Possess strong working knowledge of DDMAC guidance and applies understanding to business situations
• Based upon sound regulatory knowledge, make and execute challenging decisions, understanding when a decision should be elevated to upper management for further consideration
• Advise Regulatory Operations group regarding special requirements for FDA 2253 submissions
• Work closely with RA labeling group regarding package insert changes to assure that promotional PI and important safety information are updated as appropriate

Preferred Qualifications

• A Master’s, Ph.D. or Pharm D is preferred
• 5 years advertising and promotion regulatory experience is preferred, medical/scientific affairs experience may be considered

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs