Associate Director, Regulatory Affairs Advertising & Promotion (Hybrid)

About the role

The Associate Director, Regulatory Affairs US Advertising and Promotion is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executing multidivisional initiatives. The role involves making decisions and plans for operations, aligning and maintaining effective communication channels, managing the departmental budget, and encouraging innovation.

Responsibilities

• Makes 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.

Qualifications

• Bachelor's degree
• 8+ years of relevant experience (e.g., applicable pharmaceutical/medical devices/biologics experience, pharmacy rotations, Public Health, etc.) OR 6 years and more with advanced degree
• Experience in US Regulatory Affairs Advertising and Promotion
• Experience developing and implementing successful global regulatory strategies

Preferred Qualifications

• Advanced degree preferred: MS, MPH, MSN, PA, DNP, PhD, PharmD, JD, MD degree
• Experience in management capacity preferred

Other Required Skills

• Experience working in a complex and matrix environment
• Strong communication skills, both oral and written