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

About the Company

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 are developed, manufactured, or distributed to meet required legislation. The individual develops and supervises regulatory professionals as needed, supports the Director in efforts to influence the regulatory environment, and leads the department as a subject matter expert (SME) for Regulatory.

Responsibilities

• Proactively capture and disseminate activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie’s interests.
• Maintain awareness of pending changes to communicate impact and relevance within Regulatory Operations.
• Draft and finalize comments in a timely manner to regulators and trade associations; distribute proposed policies to SMEs and highlight key points concisely.
• Represent the department and participate in trade associations as needed; develop good working relationships with trade association managers.
• Summarize findings in concise reports for distribution within AbbVie.
• Oversee operations productivity and development of assigned regulatory staff responsible for ensuring advertising and promotion 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.
• Broadly apply regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Ensure departmental training and compliance with established regulations, guidance, promotional guidelines, and SOPs related to advertising and promotion regulations for self and direct reports.
• Manage direct reports and assist in the development, training, and mentoring of staff members.
• Effectively present pertinent information to appropriate cross-functional groups.
• 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.) fostering mutually beneficial interactions and exchange.

Requirements

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

Schedule

This role will work a hybrid work schedule (3 days in office & 2 days remotely) from one of the following AbbVie headquarters: Lake County, IL; Florham Park, NJ; Irvine, CA.

Benefits

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

Additional Information

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