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 captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie’s interests.
• Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations.
• Drafts and finalizes comments in a timely manner to regulators and trade associations.
• Distributes proposed policies to SMEs, highlighting key points in a clear and concise manner.
• Represents the department and participates in trade associations as needed, developing good working relationships with trade association managers.
• Summarizes findings, under supervision, in concise reports for distribution within AbbVie.
• Oversees the 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.
• Develops and guides implementation strategies for promotional activities.
• Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Ensures departmental training and compliance with established regulations, guidance, promotional guidelines, and SOPs related to advertising and promotion regulations for self and direct reports.
• Manages direct reports and assists in the development, training, and mentoring of staff members.
• Effectively presents pertinent information to appropriate cross-functional groups.
• Delivers difficult messages to commercial organizations without damaging relationships.
• Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.), fostering mutually beneficial interactions and exchange.

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.

Requirements

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

Qualifications

Minimum:

• 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.).
• Experience working in a complex and matrix environment with strong negotiation skills.
• Strong communication skills, both oral and written.

Preferred:

• PharmD degree plus 5 years of relevant industry experience (e.g., regulatory affairs fellowship, Health Authority, ad promo, etc.).
• Experience in a management capacity.
• Experience in US Regulatory Affairs Advertising and Promotion.

Benefits

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

This job is eligible for participation in AbbVie’s long-term incentive programs.

Schedule

Hybrid work schedule (3 days in office & 2 days remotely).