Senior Manager, Regulatory Strategic Planning - Hybrid

About the role

The Senior Manager, Regulatory Strategic Planning, is responsible for successfully delivering project management capabilities for cross-functional teams of medium- to high-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

• 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.
• Plans and executes process improvement initiatives of medium-to high-complexity; demonstrates effective change leadership and 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.
• Led 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.
• Covers budget, contracts, communications, metrics, and reporting-related processes; coordinates and drives deliverable preparation.
• 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.

Requirements

• 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 from the Regulatory Affairs Professionals Society, and/or Project Management Institute (PMI) Project Management Professional (PMP) are preferred
• 7 years' related experience
• Proven leadership skills and presence. Ability to interact with senior management and executives
• Experience working in a complex and matrix environment
• Strong verbal and written communication skills

Qualifications

• Must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays.
• Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k)
• This job is eligible to participate in our long-term incentive programs.

Pay

$124,500 - $236,500 USD

Schedule

Hybrid (3 days in office)