Senior Manager, Regulatory Affairs US Advertising and Promotion - Immunology - Hybrid

About the Role

The Senior Manager Regulatory Affairs US Advertising and Promotion-Immunology combines knowledge of scientific, regulatory, and business issues to enable products that meet required legislation. This individual develops and supervises regulatory professionals, supports the Director in influencing the regulatory environment, and serves as a subject matter expert (SME) for Regulatory Affairs. The role involves analyzing broad implications of changing regulations and policies, leading departmental initiatives, and fostering cross-functional relationships.

Responsibilities

• Proactively monitor and disseminate activities of government, industry, and trade associations impacting pharmaceutical regulatory policies relative to AbbVie’s interests.
• Maintain awareness of pending regulatory changes and communicate their impact and relevance within Regulatory Operations.
• Draft and finalize comments for regulators and trade associations in a timely manner, distributing proposed policies to SMEs and summarizing key points concisely.
• Represent the department and participate in trade associations as needed, developing working relationships with trade association managers.
• Oversee the productivity and development of regulatory staff responsible for ensuring advertising and promotional materials comply with internal policies, CFR, FDA guidance, PhRMA Guiding Principles, and the FDA and Cosmetic Act.
• Develop and guide implementation strategies for promotional activities.
• Apply regulatory and technical knowledge of government regulations across therapeutic areas.
• Ensure departmental training and compliance with established regulations, guidance, promotional guidelines, and SOPs for self and direct reports.
• Manage direct reports and assist in the development, training, and mentoring of staff.
• Present pertinent information effectively to cross-functional groups and deliver difficult messages to commercial organizations without damaging relationships.
• Establish solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) to foster mutually beneficial interactions.

Requirements

• Bachelor’s degree in science (e.g., biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, nursing) plus 7 years of relevant industry experience (e.g., regulatory affairs fellowship, Health Authority, ad promo).
• Preferred: PharmD degree plus 5 years of relevant industry experience.
• Experience working in a complex, matrix environment with strong negotiation skills.
• Strong oral and written communication skills.
• Experience in a management capacity preferred.
• Experience in US Regulatory Affairs Advertising and Promotion.

Schedule

This role follows a hybrid work schedule: 3 days in the office and 2 days remotely from one of AbbVie’s headquarters in Lake County, IL; Florham Park, NJ; or Irvine, CA.

Benefits

• Comprehensive package including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Eligibility to participate in long-term incentive programs.

Significant Work Activities

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day) is required.