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Senior Manager, Regulatory Affairs US Advertising and Promotion (Irvine, CA or Remote)
The Senior Manager Regulatory Affairs US Advertising and Promotion, combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. 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. Shares knowledge and expertise with others in support of team activities. Analyzes broad scope implications of changing regulations and policies.
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 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 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’s, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Manages direct reports and assist in the development, training and mentoring of staff members
Effectively presents pertinent information to appropriate cross-functional groups.
Effectively delivers difficult messages to commercial organization 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.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)