Director, Regulatory Affairs Information Management job opportunity at AbbVie.

Home Jobs In United States Tag: Regulatory Affairs Information Management Director, Regulatory Affairs Information Management position at AbbVie


Date2026-05-12T20:17:22.188Z bot
AbbVie Director, Regulatory Affairs Information Management
Experience: General
Pattern: Full-time
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Regulatory Affairs Information Management

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degreeGeneral
loacation North Chicago, Illinois, United States
loacation North Chicago,..........United States
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Job DescriptionThe Director of Regulatory Information Management (RIM) leads the advancement of business capabilities to enable efficient, consistent, and compliant use, and management, of Regulatory information across AbbVie and with Health Authorities. Provides strategic design, implementation, and ongoing improvements of Regulatory business capabilities. In addition, the individual is generally considered a key opinion leader and an expert resource both within AbbVie and externally. The individual may influence changing regulations and guidance, interface with outside regulatory agencies and provide executive management with RIM metrics and reports. Proposes and executes enhancement within the Regulatory Information Management vision. Provides strategic design, development, and implementation plans for the RIM Solution (Cosmos), and works alongside BTS, Business SMEs, and stakeholders to propose and lead the execution of these plans.Provides strategic design, implementation, and ongoing improvements of Regulatory business capabilities, and works closely with Regulatory Business Process Owners and other internal partners to identify, prioritize, and deliver sound RIM processes and supporting technologies in support of Regulatory strategies.Leverages a working knowledge of Regulatory business processes across the complete drug product lifecycle including A&A, Safety, Clinical, Development, PDS&T, Quality, and Operations to transform improvement concepts into executable initiatives. Seeks input from and forges agreements among sponsors regarding initiative goals and objectives across multiple domains to drive benefit across the enterprise.Oversee the implementation and maintenance of robust data to ensure the accuracy, consistency and integrity of regulatory information. Lead ongoing data review and improvement initiatives and collaborate with cross-functional teams to resolve discrepancies and ensure compliance with regulatory requirements.Drive continuous improvement of the Regulatory Information Management (RIM) system by maintaining deep expertise in its functionality and user needs. Advance RIM solutions, optimize supporting materials—including training programs and job aids—and provide effective training to staff. Represent RIM in internal and external forums, including staff meetings, regional meetings, and conferences.Define key performance indicators (KPIs) and metrics to measure the success and impact of ongoing activities and innovation efforts, regularly reporting progress to leadership. Leverage expertise and ownership of Regulatory Information to support inspections.Effectively frames complex issues for decision-makers. Prepares and delivers effective presentations that lead to actionable results. Draws upon personal knowledge of RA business processes, global regulations, and process improvement methods to propose and design innovative business process improvements.Works independently in a role that demonstrates organizational influence within or across Regulatory and partner functions.As applicable, identifies and leads project team members effectively without direct authority; motivates to drive performance, resolve conflicts and mitigate risks.

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