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

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience—and products and services in our Allergan Aesthetics portfolio.

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. The role involves analyzing broad implications of changing regulations and policies and sharing expertise to support team activities.

Responsibilities

• Proactively capture 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 while highlighting key points clearly and concisely.
• Represent the department and participate in trade associations as needed, developing strong working relationships with trade association managers.
• Summarize findings in concise reports for distribution within AbbVie.
• Oversee the productivity and development of assigned regulatory staff responsible for ensuring advertising and promotional materials are accurate, competitive, and compliant with internal policies, Code of Federal Regulations (CFR), FDA guidance documents, 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 related to advertising and promotion for self and direct reports.
• Manage direct reports and assist in the development, training, and mentoring of staff.
• Effectively present pertinent information 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.

Qualifications

• Minimum: 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 (e.g., regulatory affairs fellowship, Health Authority, ad promo).
• Experience working in a complex and matrix environment with strong negotiation skills.
• Excellent 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 office and 2 days remotely) from one of the following AbbVie headquarters: Lake County, IL; Florham Park, NJ; Irvine, CA.

Work Environment

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

Pay

The compensation range for this role is based on the job grade and may vary depending on geographic location. The range may be modified in the future. Individual compensation will be determined based on factors such as experience and location.

Benefits

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