Job Description

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 regulatory requirements. Additionally, the individual develops and supervises regulatory professionals as needed. 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 Affairs in cross-functional workstreams.  Shares knowledge and expertise with others in support of team activities. Analyzes broad scope implications of changing regulations and policies.

Responsibilities:

Reviews promotional and non-promotional communications for on-market products to ensure compliance with applicable laws and regulations, as well as internal policies and procedures. Functions independently in this role while bringing relevant topics to management as appropriate.

Provides regulatory guidance for data and information consistent with product labeling.

Participates in pipeline commercialization activities; reviews and contributes to target product claims, target product labeling.

Acts as a key contributor on cross-functional teams and workstreams for pipeline and on-market products.

Develops and guides implementation strategies for promotional activities.

Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.

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 US Advertising and Promotion department.

Represents department and participates in trade associations as needed.

Summarizes findings, under supervision, in concise reports for distribution within AbbVie

If assigned staff, oversees their operations, productivity, and development.

Ensures departmental training and compliance with established regulations, FDA guidance, promotional guidelines, and SOPs related to advertising and promotion regulations. If applicable, 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 while maintaining relationships.

Establishes good working relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Market Access, Public Affairs, etc.), fostering mutually beneficial interactions and exchange.

This role can be based remotely within the US.