Senior Manager, Regulatory Affairs US Advertising and Promotion - Immunology

Senior Manager, Regulatory Affairs US Advertising and Promotion - Immunology

Abb Vie’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: immunology, oncology, neuroscience, eye care and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at .

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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 the required legislation. The individual develops and supervises regulatory professionals as needed, supports the Director in influencing the regulatory environment, and leads the department as a subject‑matter expert (SME). This person shares expertise with others in support of team activities and analyzes broad‑scope implications of changing regulations and policies.

• Proactively capture and disseminate activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to Abb Vie’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; highlight key points in a clear and concise manner.
• Represent the department and participate in trade associations as needed; develop good working relationships with trade association managers.
• Summarize findings, under supervision, in concise reports for distribution within Abb Vie.
• Oversee the operations, productivity, and development of assigned regulatory staff responsible for ensuring that 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 cosmetics Act.
• Develop and guide implementation strategies for promotional activities.
• Apply regulatory/technical knowledge of government regulations broadly 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 development, training, and mentoring of staff members.
• Effectively present pertinent information to appropriate cross‑functional groups.
• Effectively 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.

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

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

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend…