Senior Manager, Regulatory Strategic Planning

AbbVie•North Chicago, IL

1d•$124,500 - $236,500•Hybrid

About The Position

The Senior Manager, Regulatory Strategic Planning delivers project management capabilities for cross-functional teams of medium to high complexity within and across Regulatory Affairs. The role combines scientific, regulatory, and business process knowledge to drive execution of AbbVie’s regulatory strategies. The Senior Manager develops and manages schedules, activities, and deliverables for Global Regulatory Product Teams (GRPTs), engages key stakeholders, and leads process improvement efforts that support regulatory compliance and productivity goals. The position works with Regulatory staff globally and supports GRPT operations in collaboration with the Global Regulatory Lead. It also coordinates deliverables, tracks budgets and performance metrics, facilitates meetings, and communicates program progress and issues to stakeholders and management. The role is based at AbbVie’s Lake County, Illinois headquarters and follows a hybrid schedule with three days in the office.

Requirements

Bachelor’s degree in science (biology, chemistry, microbiology, medical technology, pharmacy, or pharmacology), math, engineering, business management, or a medical field.
Seven years of related experience.
Proven leadership skills and presence, with the ability to interact with senior management and executives.
Experience working in a complex, matrixed environment.
Strong verbal and written communication skills.

Nice To Haves

Advanced degree in science, math, business management, or engineering.
Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society.
Project Management Professional (PMP) certification from the Project Management Institute.

Responsibilities

Provide project management leadership for Global Regulatory Product Teams (GRPTs), developing schedules and wave plans to plan and track regulatory milestones and driving execution of GRPT activities and deliverables with Regulatory staff worldwide.
Independently plan and facilitate GRPT and related meetings, including Dossier Kick-off Meetings, Regulatory Strategic Reviews, Rapid Response Teams, and Regulatory Advisory Panels; assign and follow up on action items and share team highlights with stakeholders.
Coordinate with ADTs and other enterprise stakeholders to communicate regulatory milestones, and update Regulatory management on progress and issues that may affect global programs.
Drive GRPT operations in support of the Global Regulatory Lead and keep GRPT information and tools, such as team sites, rosters, charters, and schedules, current.
Plan and execute medium- to high-complexity process improvement initiatives, leading change from concept through implementation.
Apply knowledge of the regulatory product lifecycle, business processes, and regulations across Regulatory sub-functions to assigned initiatives; solve problems and make decisions while adapting based on prior results and experience.
Lead team meetings, use project governance to escalate and resolve issues, facilitate groups, and build consensus on process changes.
Develop effective working relationships with project team members and prepare and deliver clear, relevant, influential reports and presentations for varied audiences.
Coordinate and drive deliverable preparation; develop and maintain process models using standard methods and tools; manage and track budgets, contracts, communications, metrics, and reporting processes.
Support mechanisms for identifying, capturing, and reporting business performance metrics; analyze metrics with subject matter experts to improve compliance, quality, and productivity.
Incorporate diverse, cross-functional, and global perspectives into strategies and tactics to improve outcomes for Regulatory Affairs.