Senior Manager, Regulatory Strategic Planning

AbbVie; North Chicago (IL); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Comprehensive benefits

Long-term incentive programs

Paid time off

Job summary

AbbVie in Lake County, IL seeks a Senior Manager, Regulatory Strategic Planning to lead cross-functional project management for Global Regulatory Product Teams (GRPTs). You will develop schedules, manage deliverables, and drive regulatory strategy execution across global stakeholders.

The role requires 7+ years of related experience, strong leadership, and a deep understanding of regulatory processes. A hybrid work model with three days in office is offered, located at our IL headquarters.

Qualifications

• Bachelor’s degree in science (biology, chemistry, microbiology, medical technology, pharmacy, pharmacology) or equivalent.
• Advanced degree in science, math, business management, or engineering is preferred; RAC/PMI-PMP certifications are a plus.
• 7 years’ related experience in regulatory or related field.
• 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.

Responsibilities

• Provide PM leadership in support of GRPTs; develop schedules and wave plans; coordinate with Regulatory staff globally.
• Plan and facilitate GRPT meetings (Dossier Kick-offs, Regulatory Strategic Reviews, Rapid Response Teams, Advisory Panels).
• Ensure action items are tracked and summarized for stakeholders.
• Interact with ADTs and key stakeholders to communicate milestones; provide timely updates on progress/issues.
• Drive GRPT operations to support the Global Regulatory Lead; keep team sites, rosters, charters, and schedules up to date.
• Plan and execute medium-to-high complexity process improvements; demonstrate change leadership.
• Lead team meetings; use governance processes to resolve issues and drive consensus on changes.
• Build working relationships; deliver clear written reports and presentations to various audiences.
• Coordinate deliverable preparation; maintain process models; manage budgets, contracts, communications, metrics.
• Identify, capture, and report business performance metrics to improve compliance, quality, and productivity.
• Work a hybrid schedule (3 days in office) at AbbVie Lake County, IL headquarters.

Skills

Regulatory project management

Cross-functional leadership

Stakeholder communication

Regulatory lifecycle knowledge

Process improvement

Education

Bachelor’s degree in science

Advanced degree preferred

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 LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

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. The Senior Manager will be developing and managing the schedules, activities, and deliverables for the Global Regulatory Product Teams (GRPTs), interacting with key stakeholders, and leading 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.
• Plans and execute 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.
• 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.
• 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.
• This role will work a hybrid work schedule (3 days in office) from our AbbVie Lake County, IL headquarters.

Significant Work Activities

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

Qualifications

• 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

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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