Manager, Regulatory Information Management

Regulatory Jobs; North Chicago (IL); Hybrid; USD 100,000 - 150,000; Full time

Job summary

AbbVie is seeking a Manager, Regulatory Information Management to advance regulatory data capabilities. The role drives data integration, quality, and lifecycle management across the Regulatory Affairs organization and the enterprise.

You will supervise cross-functional teams, manage schedules, and deliver enhancements for compliance and productivity. The position supports a hybrid schedule at AbbVie Lake County, IL.

Qualifications

• 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 - Cross-functional collaboration
• Ability to manage budget and timelines of projects and resources within a program or department
• Strong attention to detail and problem solving skills
• Keen awareness to cultural nuances; work in a global environment across multiple divisions

Responsibilities

• Provides input into and executes against strategies for regulatory information and supporting technologies
• Develops, executes and implements business processes for data integration, maintenance and remediation
• Executes process improvement initiatives of low- to medium- complexity; drives ideas to implementation
• Leads team meetings; escalates issues using governance; prepares reports for audiences
• Coordinates deliverables; maintains process models; tracks communications and metrics
• May supervise, mentor, and train staff

Skills

Leadership

Communication

Cross-functional teamwork

Project governance

Education

Bachelor's degree in science

Advanced degree in science

RAC or PMP certification (preferred)

Tools

Microsoft Project

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

. Follow @abbvie on

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The Manager, Regulatory Information Management

contributes to the advancement of business capabilities to enable efficient, consistent, and compliant use, and management, of Regulatory information across AbbVie and with Health Authorities. Offers input to and execution against strategic design, implementation, and ongoing improvements of Regulatory business capabilities. Responsible for successfully delivering enhancement projects for cross-functional teams of low- to medium complexity within and across the Regulatory Affairs organization and the enterprise. Responsibilities include developing and managing the schedules, activities, and deliverables for projects, interacting with key stakeholders, and leading process improvement efforts to help achieve business performance goals for regulatory compliance and productivity. May supervise staff.

Responsibilities:

• Provides input into and executes against strategies and opportunities that may span multiple locations, functions or organizations around regulatory information and supporting technologies
• Develops, executes and implements business processes for data integration, maintenance and remediation. Conducts impact assessments, develops strategies for implementing and maintaining data quality
• Executes process improvement initiatives of low- to medium- complexity; can move ideas from concept to implementation. Possesses proficient knowledge of the regulatory product lifecycle, business processes, and regulations across Regulatory sub-functions; can provide business subject matter knowledge on assigned initiatives, and demonstrates effective problem solving and 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 communications, metrics, and reporting-related processes. Incorporates diverse, cross-functional, and global perspectives into strategies and tactics that consistently enhance the ability to improve outcomes for the Regulatory Affairs organization.
• May be responsible for managing, mentoring, directing and training staff.

This role will work a hybrid work schedule (3 days in office) from the AbbVie Lake County, IL offices.

Significant Work Activities:

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

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

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:

• In addition to the required 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 also compensate for lower education.