Senior Manager, Regulatory Strategic Planning

Role Summary

The Senior Manager, Regulatory Strategic Planning is responsible for delivering project management capabilities for cross-functional teams of medium- to high-complexity within and across the Regulatory Affairs organization. This role combines knowledge of scientific, regulatory, and business processes to drive the execution of AbbVie’s regulatory strategies, including developing and managing schedules, activities, and deliverables for Global Regulatory Product Teams (GRPTs), coordinating with stakeholders, and leading process improvement to enhance 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.
• Plans and facilitates GRPT and related meetings; ensures action items are assigned and completed; summarizes and shares team highlights with stakeholders as necessary.
• Interacts with ADTs and other key stakeholders to ensure regulatory milestones are properly communicated; provides timely updates on progress and issues that may impact the global program.
• Drives GRPT operations in support of the Global Regulatory Lead (GRL); ensures GRPT-related information and tools are kept up to date.
• Plans and executes process improvement initiatives of medium- to high-complexity; demonstrates effective change leadership and moves ideas from concept to implementation.
• Possesses proficient knowledge of the regulatory product lifecycle, business processes, and regulations; provides subject matter knowledge on assigned initiatives; demonstrates problem-solving and decision-making, and learning from prior results/experience.
• Leads team meetings effectively; escalates and drives resolution of issues through the project governance process; facilitates consensus on process changes.
• Develops working relationships with project team members; prepares and delivers clear, relevant reports and presentations for various audiences.
• Coordinates and drives deliverable preparation; maintains process models; manages and tracks budgets, contracts, communications, metrics, and reporting processes.
• Supports mechanisms to identify, capture, and report business performance metrics; analyzes metrics with SMEs to improve compliance, quality, and productivity; incorporates cross-functional perspectives into strategies to improve outcomes for Regulatory Affairs.

Qualifications

• Bachelor’s degree in science (biology, chemistry, microbiology, medical technology, pharmacy, pharmacology), math, engineering, business management, or medical field
• Advanced degree in science, math, business management, or engineering is preferred
• Certifications such as RAC and/or PMI Project Management Professional (PMP) are preferred
• 7 years’ related experience
• Proven leadership skills and presence
• Experience in a complex and matrix environment
• Strong verbal and written communication skills
• Ability to interact with senior management and executives