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Senior Manager, Regulatory Affairs Operations

2 months ago

North Chicago Illinois, United States AbbVie Full time
Job Summary

The Senior Manager, Regulatory Strategic Planning, is a key member of the AbbVie team responsible for delivering project management capabilities for cross-functional teams of medium- to high-complexity within and across the Regulatory Affairs organization.

Key Responsibilities
  • Project Management Leadership: Provides project management leadership in support of Global Regulatory Product Teams (GRPTs); develops schedules and wave plans to ensure regulatory milestones are adequately planned and tracked.
  • Meeting Facilitation: Works independently to plan and facilitate GRPT and related meetings; ensures action items are assigned and completed.
  • Stakeholder Engagement: Interacts with key stakeholders across the enterprise to ensure regulatory milestones are properly communicated.
  • Process Improvement: Drives GRPT operations in support of the Global Regulatory Lead (GRL); plans and executes process improvement initiatives of medium- to high-complexity.
  • Business Acumen: Possesses proficient knowledge of the regulatory product lifecycle, business processes, and regulations across Regulatory sub-functions.
  • Team Leadership: Leads team meetings effectively; uses the project governance process to effectively escalate and drive resolution of issues.
Requirements
  • Regulatory Knowledge: Proficient knowledge of the regulatory product lifecycle, business processes, and regulations across Regulatory sub-functions.
  • Project Management: Proven project management skills, including schedule development and tracking, resource allocation, and issue escalation.
  • Communication: Excellent written and verbal communication skills, with the ability to prepare and deliver clear, relevant, and influential reports and presentations.
  • Leadership: Demonstrated leadership skills, with the ability to drive consensus among team members regarding process changes.