Senior Manager, Regulatory Affairs Process Excellence

Regulatory Toolkit; Chicago (IL); Hybrid; USD 140,000 - 190,000; Full time

Job summary

AbbVie is seeking a Senior Manager, Process Excellence within Regulatory Affairs to lead process improvement and issue management across Regulatory Affairs operations. You will oversee RAIM, triage issues, escalate risks, and partner with Quality, Business Process Owners, and other functions to drive changes and inspection readiness.

The role supports internal and external audits and manages legacy integrations in Regulatory Affairs.

Qualifications

• Strong organizational, analytical, communication, facilitation, and stakeholder management skills.
• Ability to manage multiple priorities and work effectively across functions and levels.
• Ability to influence without direct authority and operate in a matrixed environment.

Responsibilities

• Manage Regulatory Affairs Issue and CAPA Management system (RAIM) to ensure issues are logged, tracked, and resolved.
• Triages RAIM issue records to determine severity, impact, and next steps.
• Escalates issue records to Exception Reports based on risk and process significance.
• Projects manage Exception Reports with cross-functional stakeholders to identify root causes and drive corrective actions.
• Collaborate with Regulatory Affairs leaders and Quality to ensure timely issue management and change controls.
• Support audits and inspections, including documentation coordination and responses as needed.
• Manage legacy integrations for Regulatory Affairs processes through change plans in OneTrack.

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, Xand YouTube.

Senior Manager, Process Excellence within Regulatory Affairs, is responsible for managing key process excellence and issue management activities that support compliant, efficient, and inspection-ready Regulatory Affairs operations. This role oversees the Regulatory Affairs Issue and CAPA Management system (RAIM), triages issue records, escalates issues to Exception Reports when warranted, and partners cross-functionally to drive process improvements. Through collaboration with functional and cross-functional stakeholders, the position also supports inspection readiness and audit/inspection response activities, and management of change plans for legacy company integrations into Regulatory Affairs business processes.

Responsibilities:

• Manage the Regulatory Affairs Issue and CAPA Management system (RAIM) to ensure issues are appropriately logged, assessed, tracked, and resolved
• Triage RAIM issue records to determine severity, impact, and appropriate next steps
• Escalate issue records to Exception Reports when needed based on risk, compliance impact, or process significance
• Project manage Exception Reports in partnership with cross-functional stakeholders to identify root causes, drive corrective actions, and improve AbbVie processes
• Collaborate with Regulatory Affairs leaders, Business Process Owners, Quality, and other functions to ensure issue management activities are timely, well-coordinated, and effective
• May provide support during internal and external audits and inspections, including coordination of documentation, issue follow-up, and response support as needed
• Manage multiple legacy company integrations for Regulatory Affairs business processes through change plans in OneTrack
• Ensure process documentation, issue records, and change plans are maintained accurately and in alignment with applicable governance expectations
• Partner with stakeholders to support effective communication, implementation, and adoption of process changes.
• This role will work a hybrid work schedule (3 days in office, 2 days remotely) from our Lake County, ILAbbVie headquarters.

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 life sciences (pharmacy, biology, chemistry, pharmacology or related subject). Preferred Education: Relevant advanced degree in science or business is preferred. Certification a plus
• Required Experience: 8+ years of regulatory, pharmaceutical or device experience.
• Experience in Regulatory Affairs, Quality, process excellence, business process management, or related roles is preferred
• Experience managing issue/CAPA systems, exception reporting, or comparable compliance and investigation workflows
• Experience supporting audit and inspection readiness in a regulated environment
• Strong organizational, analytical, communication, facilitation, and stakeholder management skills
• Ability to manage multiple priorities and work effectively across functions and levels
• Ability to influence without direct authority and work in a matrixed environment

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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