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.
Requirements
- Knowledge of scientific, regulatory and business issues related to pharmaceutical regulatory affairs.
- Experience in regulatory affairs, specifically in advertising and promotion compliance.
- Understanding of Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and Cosmetic Act.
- Ability to draft and finalize comments to regulators and trade associations.
- Experience managing and developing regulatory professionals.
- Strong communication skills to present information to cross-functional teams and deliver difficult messages.
- Ability to analyze broad scope implications of changing regulations and policies.
- Experience ensuring advertising and promotion materials are compliant with internal policies and regulations.
Nice to Have
- Recognized as a subject matter expert (SME) in regulatory affairs.
- Experience influencing the regulatory environment.
- Experience representing department in trade associations.
- Proven ability to supervise and mentor staff.
Work Arrangement
Hybrid — Lake County, IL, Florham Park, NJ, Irvine, CA, Washington, D.C., Rockville, MD
Additional Information
- Work schedule is hybrid: 3 days in office and 2 days remotely.
- Significant work activities include continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day).
