Senior Manager Regulatory Affairs US Advertising and Promotion - US Specialty

Company Description

About AbbVie

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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager, Regulatory Affairs US Advertising and Promotion – US Specialty combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies.

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. Highlights key points in a clear and concise manner.
• Represents department and participates in trade associations as needed. Develops 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 that are 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 Federal Food, Drug, 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 (where applicable). Manages direct reports (where applicable) and assists in the development, training and mentoring of staff members.
• Effectively presents pertinent information to appropriate cross-functional groups
• Effectively delivers difficult messages to commercial organizations without damage to relationships
• Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) by fostering mutually beneficial interactions and exchange
• This role will work a hybrid work schedule from our Mettawa, IL; Florham Park, NJ or Irvine, CA AbbVie headquarters. 

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

• 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 promo, etc.)
• Preferred PharmD degree plus 5 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
• Experience working in a complex and matrix environment and exhibits strong negotiation skills
• Strong communication skills, both oral and written
• Experience in management capacity preferred
• Experience in US Regulatory Affairs Advertising and Promotion required

Additional Information

Applicable only to applicants applying to a posit