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AbbVie is hiring a Senior Specialist, Regulatory Strategic Planning

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North Chicago, North Chicago
Posted an hour ago
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Job Description

The Senior Associate, Regulatory Strategic Planning, is responsible for successfully delivering project management capabilities for cross-functional teams within the Regulatory Affairs organization. The individual combines knowledge of scientific, regulatory, and business processes to properly drive the execution of AbbVie’s regulatory strategies. Responsibilities include developing and managing the schedules, activities, and deliverables for the Global Regulatory Product Teams (GRPTs), interacting with key stakeholders, and supporting process improvement efforts to help achieve business performance goals for regulatory compliance and productivity.

Responsibilities

  • Provides project management leadership in support of GRPTs; develops schedules and wave plans to ensure regulatory milestones are adequately planned and tracked, and works with Regulatory staff across the globe to drive the execution of GRPT-related activities and deliverables.
  • Works independently to plan and facilitate GRPT and related meetings (e.g., Dossier Kick-off Meetings, Regulatory Strategic Reviews, Rapid Response Teams, and Regulatory Advisory Panels); ensures action items are assigned and completed; periodically summarizes and shares team highlights with stakeholders as necessary.
  • Interacts with ADTs and other key stakeholders across the enterprise to ensure regulatory milestones are properly communicated; periodically communicates with Regulatory management to provide timely updates on progress and/or issues that may impact the global program.
  • Drives GRPT operations in support of the Global Regulatory Lead (GRL); ensures GRPT-related information and tools (e.g., team sites, rosters, charters, schedules) are kept up to date. Executes process improvement initiatives of low- to medium-complexity; demonstrates effective change leadership, and is able to move ideas from concept to implementation.
  • Possesses working knowledge of the regulatory product lifecycle, business processes, and regulations across Regulatory sub-functions; is able to provide business subject matter knowledge on assigned initiatives, and demonstrates effective problem solving & decision making, learning and adjusting behaviors based on prior results/experience.
  • Leads team meetings effectively; uses the project governance process to effectively escalate and drive resolution of issues; demonstrates effective group facilitation skills and ability to drive consensus among team members regarding process changes.Develops effective working relationships with project team members; prepares and delivers clear, relevant, and influential written reports and presentations for a variety of audiences.
  • Develops effective working relationships with project team members; prepares and delivers clear, relevant, and influential written reports and presentations for a variety of audiences.Coordinates and drives deliverable preparation; develops and maintains process models using standard methods and tools; manages and tracks budgets, contracts, communications, metrics, and reporting-related processes.
  • Supports mechanisms to identify, capture, and report business performance metrics. Analyzes metrics with subject matter experts in an effort to drive increase compliance, quality, and productivity across the organization.Incorporates diverse, cross-functional, and global perspectives into strategies & tactics that consistently enhance the ability to improve outcomes for the Regulatory Affairs organization.
  • This position will work a hybrid work schedule (3 days in office) from our Lake County, IL AbbVie headquarters. 

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

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Salary Information

Salary: $110000-150000

🤖 This salary estimate is calculated by AI based on the job title, location, company, and market data. Use this as a guide for salary expectations or negotiations. The actual salary may vary based on your experience, qualifications, and company policies.

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