Manager, Regulatory Information Management

Company 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 LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

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

Qualifications

• 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 requirem