Associate Director, Regulatory Affairs Strategic Global Labeling & Operations

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Associate Director, Regulatory Affairs Strategic Global Labeling and Operations, provides leadership, employee management, strategy and program management for Regulatory Affairs in the area of labeling using our current systems. Provides leadership in the optimization or development of new business processes, identifying business requirements and managing data migration into future systems. The Associate Director, leads cross-functional, multidisciplinary teams, and executes initiatives on projects having significant financial, legal or regulatory implications and manages staff and may manage a department.

Responsibilities:

• Serves as the subject matter expert (SME) relating to label management for Regulatory Affairs to develop strategies, processes and reporting tools and communicates these to management.
• Comprehends the overall dependencies and impacts between label management and other types of submissions to build the most effective program for management of our data and documents.
• Interacts with all areas of Regulatory Affairs, affiliates and other departments within the greater pharmaceutical organization.
• Sets business product direction with vendors to assure that AbbVie’s requirements are met in future releases and enhancements.
• Contributes to the development, coordination and execution of business processes with other regulatory departments, affiliates and other divisions.
• Interacts with IT, business and management across Regulatory Affairs and with external companies to develop and update multi-year strategic plans related to label management.
• Able to pull accurate metrics, queries and reports from regulatory systems and provide to Senior Management and/o