Associate Director, Regulatory Affairs - Advertising & Promotion

Role Summary

The Associate Director, Regulatory Affairs US Advertising and Promotion sets strategy, leads cross-functional, multidisciplinary teams, and drives multidivisional initiatives. The role analyzes issues and trends affecting the business, identifies cross-organizational opportunities, and applies broad industry knowledge to guide regulatory strategy for advertising and promotions. This position is hybrid (3 days in office) based at AbbVie Mettawa, IL or Florham Park, NJ.

Responsibilities

• Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives.
• Maintains and evaluates productivity metrics to project current and future business needs
• Aligns and maintains effective communication channels with key Medical, Marketing, Regulatory, Legal and Public Affairs counterparts. Identifies areas of improvement in process/policy, develops recommendations/plan, and leads initiatives.
• Assists in the management of the departmental budget, identifies and communicates budgetary needs to Operations and Finance, and identifies and projects current and future expenditures and business needs.
• Operates independently, with recognition of when to consult departmental senior concerning risks. In absence of Director, is responsible for day-to-day operations. Responsible for departmental initiatives, which have significant impact on both internal and external customers.
• Encourages innovation and holds employees accountable for delivering on their goals; recognizes, mentors, rewards and recommends promotion for staff members based on their performance, results, and development.
• Exhibits solid understanding of regulations, and guidance of regulatory authorities, political and legal climate and industry practices related to advertising and promotions to assist in meeting organizational goals. Possesses and leverages broad industry knowledge
• Develops and implements complex processes and projects and develops and delivers strategic presentations for senior management
• Identifies areas of improvement in process, policy, develops recommendations/plan and leads initiatives
• This role will work a hybrid work schedule (3 days in office) from our AbbVie Mettawa, IL or Florham Park, NJ headquarters.

Qualifications

• Bachelor’s degree plus 8+ years of relevant experience (e.g. Applicable pharmaceutical/medical devices/biologics experience, pharmacy rotations Public Health, etc.)
• Advanced degree preferred: MS, MPH, MSN, PA, DNP, PhD, PharmD, JD, MD degree plus 6 years of relevant industry experience. Certification a plus.
• Experience in US Regulatory Affairs Advertising and Promotion highly preferred
• Experience working in a complex and matrix environment
• Strong communication skills, both oral and written
• Experience developing and implementing successful global regulatory strategies
• Experience in management capacity preferred