Senior Manager, Regulatory Affairs US Advertising and Promotion - Immunology (Remote)

Role Summary

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 applicable legislation. The role includes developing and supervising regulatory professionals as needed and supporting the Director in efforts to influence the regulatory environment. The Senior Manager is recognized as an expert and SME for Regulatory, providing knowledge across the team and analyzing broad implications of changing regulations and policies. This position is remote.

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
• Oversee 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 FDA and cosmetic Act.
• Development and guides implementation strategies for promotional activities
• Broadly applies 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. Manages direct reports 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.) fostering mutually beneficial interactions and exchange.

Qualifications

• Required: 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.)
• Required: Experience working in a complex and matrix environment and exhibits strong negotiation skills
• Required: Strong communication skills, both oral and written
• Preferred: Experience in management capacity
• Preferred: Experience in US Regulatory Affairs Advertising and Promotion

Additional Requirements

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