Senior Manager, Regulatory Strategic Planning

AbbVie; Illinois; Hybrid; USD 130,000 - 190,000; Full time

Benefits offered by this job

Long-term incentive programs

Comprehensive benefits package

401(k) plan

Job summary

AbbVie in Lake County, IL seeks a Senior Manager, Regulatory Strategic Planning to lead cross-functional regulatory projects, develop schedules, and drive GRPT activities with stakeholders to meet milestones.

This role requires a science degree and substantial regulatory experience, with leadership in matrix environments and strong written/verbal communication. A RAC or PMP is preferred, with a hybrid work schedule.

Qualifications

• Bachelor’s degree in science (biology, chemistry, microbiology, medical technology, pharmacy, pharmacology) required.
• Advanced degree preferred; RAC and/or PMP certifications are advantageous.
• 7 years of related regulatory or project-management experience.
• Strong verbal and written communication skills essential.

Responsibilities

• Provides project management leadership in support of GRPTs; develops schedules and wave plans; drives GRPT execution.
• Plans and facilitates GRPT meetings; ensures action items are completed and shared with stakeholders.
• Interacts with ADTs and other stakeholders to communicate milestones and progress.
• Drives GRPT operations and ensures information/tools are up to date.
• Plans and executes medium-to-high complexity process improvements and changes.
• Offers SME knowledge on regulatory product lifecycle and business processes.
• Leads team meetings; uses governance to resolve issues and drive consensus.
• Prepares clear, influential reports and presentations for diverse audiences.
• Coordinates deliverables; maintains process models and tracks budgets, contracts, and metrics.

Skills

Leadership

Regulatory knowledge

Cross-functional collaboration

Written communication

Education

Bachelor’s degree in science or related field

Advanced degree (science/math/engineering/business)

RAC certification

PMP certification

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.

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.

• 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

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• 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 employer 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html