Project Manager, Regulatory Strategic Planning, Regulatory Affairs

The Manager, Regulatory Strategic Planning, is responsible for successfully delivering project management capabilities for cross-functional teams of low- to medium-complexity within and across 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 leading process improvement efforts to help achieve business performance goals for regulatory compliance and productivity.

Major 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 (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; provides 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; is able to move ideas from concept to implementation.
• Possesses proficient 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.
• 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.

Required Education:

• Bachelor's degree in science (biology, chemistry, microbiology, medical technology, pharmacy, pharmacology), math, engineering, business management, or medical field

Preferred Education:

• Advanced degree in science, math, business management, or engineering
   Certifications such as RAC from the Regulatory Affairs Professionals Society, and/or Project Management Institute (PMI) Project Management Professional (PMP)

Required Experience:

• 5 years' related experience
• Proven leadership skills and presence
• Experience working in a complex and matrix environment
• Strong verbal and written communication skills
• Ability to interact with senior management and executives
• Ability to work with cross-functional teams
• Ability to manage budget and timelines of projects and resources within a program or department
• Ability to manage a budget and forecast financial requirements
• Strong attention to detail and problem solving skills
• Effective use of negotiation skills to resolve issues in cross-functional teams to ensure completion of assigned tasks
• Keen awareness to cultural nuances; proven ability to work in a global environment
• Ability to successfully interact with multi-divisional and multi-functional teams from across the globe

Preferred Experience:

• 3-5 years in pharmaceutical, healthcare or regulated industry
• Proficient in project planning and management including successful implementation of business process initiatives
• Experience facilitating process modeling and redesign initiatives
• Training and/or experience with process modeling tools
• Knowledge of Continuous Improvement/Lean Six Sigma concepts

Note: Higher education may compensate for years of experience; years of experience may compensate for education