The Director Regulatory Affairs, US Advertising and Promotion is responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching regulatory strategy and brand plan. He/she will contribute to strategic planning for the department (and departmental achievement of initiatives to meet goals and plan), manage assigned projects, and develop individual and team performance within the assigned franchise. The Director will also network and benchmark outside of AbbVie to provide for best practices and processes.

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.
• This role will work a hybrid work schedule (3 days in office) from our Mettawa, IL AbbVie headquarters.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required