Senior Specialist, Regulatory Strategic Planning

Regulatory Jobs; North Chicago (IL); Hybrid; USD 90,000 - 120,000; Full time

Job summary

AbbVie is seeking a Senior Associate in Regulatory Strategic Planning to lead project management for cross-functional Regulatory Product Teams (GRPTs). The role intertwines scientific, regulatory, and business processes to drive regulatory strategies, timelines, and deliverables across the globe.

You will plan schedules, manage wave plans, facilitate key meetings, and communicate progress to stakeholders while supporting process improvements in a hybrid Lake County, IL environment.

Qualifications

• 3 years’ related experience in regulatory, pharmaceutical, or healthcare environments.
• Strong verbal and written communication across global teams.
• Ability to manage budgets and forecast financial requirements.

Responsibilities

• Provides project management leadership for GRPTs; develops schedules and wave plans to ensure regulatory milestones are planned and tracked.
• Plans and facilitates GRPT and related meetings; ensures action items are assigned and completed; summarizes progress for stakeholders.
• Interacts with ADTs and key stakeholders to report milestones and issues impacting the global program.
• Drives GRPT operations and maintains tools, charters, schedules; implements low- to medium-complexity process improvements.
• Demonstrates problem solving and decision making; builds effective working relationships and clear reports for audiences.
• Coordinates deliverable preparation; manages budgets, contracts, communications, metrics, and reporting processes.

Skills

Leadership

Cross-functional teamwork

Communication skills

Education

Bachelor’s degree in science or related field

Tools

Process modeling tools

Job description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at

www.abbvie.com

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Senior Associate, Regulatory Strategic Planning

is responsible for successfully delivering project management capabilities for cross-functional teams within 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 supporting process improvement efforts to help achieve business performance goals for 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.

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. Executes process improvement initiatives of low- to medium-complexity; demonstrates effective change leadership, and is able to move ideas from concept to implementation.

Possesses working 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 elevate 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.

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.

Significant Work Activities

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

This position will work a hybrid work schedule (3 days in office) from our Lake County, IL AbbVie headquarters.

Required experience

• - 3 years’ related experience
• - Proven leadership skills and presence, Experience working in a complex and matrix environment
• - Strong verbal and written communication skills, Ability to work with cross-functional teams
• - Ability to manage a budget and forecast financial requirements, Strong attention to detail and problem solving skills
• - Ability 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 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

Required Education

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

Preferred Education

Certifications such as RAC from the Regulatory Affairs Professionals Society, and/or Project Management Institute (PMI) Project Management Professional (PMP) are a plus