Remote opportunity at
AbbVieSenior Manager, Regulatory Affairs Process Excellence
AbbVie seeks a Senior Manager, Regulatory Affairs Process Excellence to join its organization. The company focuses on discovering and providing innovative therapeutics and solutions to tackle…
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About This Role
AbbVie seeks a Senior Manager, Regulatory Affairs Process Excellence to join its organization. The company focuses on discovering and providing innovative therapeutics and solutions to tackle significant health issues across various medical fields, including oncology, immunology, neuroscience, and aesthetics. In this position, the professional oversees critical process improvement and issue resolution workflows to maintain compliant, inspection-ready operations. The person in this role manages the Regulatory Affairs Issue and CAPA Management…
Job Description
AbbVie seeks a Senior Manager, Regulatory Affairs Process Excellence to join its organization. The company focuses on discovering and providing innovative therapeutics and solutions to tackle significant health issues across various medical fields, including oncology, immunology, neuroscience, and aesthetics. In this position, the professional oversees critical process improvement and issue resolution workflows to maintain compliant, inspection-ready operations.
The person in this role manages the Regulatory Affairs Issue and CAPA Management system (RAIM), evaluates and categorizes issue logs, escalates matters into Exception Reports when necessary, and collaborates cross-functionally to execute corrective actions. Additional duties involve supporting internal and external audits, guiding change initiatives for legacy integrations within OneTrack, and ensuring alignment with applicable governance guidelines.
This opportunity is well-suited for a regulatory or quality professional with extensive pharmaceutical or medical device background who excels at matrixed collaboration, investigation workflows, and process optimization. The position follows a hybrid schedule requiring staff to work from the Lake County, Illinois headquarters three days per week and remotely for the remaining two days. Eligible employees receive a comprehensive benefits package, long-term incentive program eligibility, and paid time off.
Responsibilities
- Manage the Regulatory Affairs Issue and CAPA Management system (RAIM) to log, evaluate, track, and resolve operational issues
- Evaluate RAIM records to assess severity, impact, and required next steps
- Escalate issues to Exception Reports based on risk, compliance concerns, or process significance
- Partner with cross-functional teams to project manage Exception Reports, identify root causes, and implement corrective actions
- Collaborate with Business Process Owners, Quality teams, and Regulatory Affairs leaders to coordinate effective issue management
- Provide support during internal and external inspections and audits by handling documentation, issue follow-up, and response tasks
- Oversee legacy company integration change plans for Regulatory Affairs business processes using OneTrack
- Maintain accurate process documentation, issue logs, and change plans in compliance with governance standards
- Work with stakeholders to facilitate the communication and adoption of process changes
Requirements
- Bachelor's degree in a life sciences discipline such as pharmacy, biology, chemistry, pharmacology, or a related field
- At least 8 years of experience in regulatory, pharmaceutical, or medical device environments
- Background working with issue or CAPA systems, exception reporting, and compliance investigation workflows
- Experience assisting with audit and inspection readiness in regulated settings
- Strong organizational, analytical, communication, facilitation, and stakeholder management abilities
- Capability to manage multiple priorities and operate across various functions and organizational levels
- Ability to influence without direct authority within a matrixed structure
- Capacity to sit continuously for prolonged periods exceeding two consecutive hours during an eight-hour workday
Qualifications
- Relevant advanced degree in a science or business discipline
- Professional certification
- Direct experience in Regulatory Affairs, Quality, business process management, or process excellence
Core Skills
Benefits
- Paid time off including vacation, holidays, and sick leave
- Medical, dental, and vision insurance
- 401(k) retirement plan
- Eligibility to participate in long-term incentive programs
Frequently Asked Questions
What is the employment type and remote work policy for this position?
The position is a full-time role operating on a hybrid schedule, requiring three days in the office and two days remotely from the AbbVie headquarters in Lake County, Illinois.
What education and experience are required to apply?
Applicants must hold a bachelor's degree in a life sciences subject like pharmacy, biology, chemistry, or pharmacology, along with a minimum of 8 years of regulatory, pharmaceutical, or device experience.
What benefits are offered for this job?
Eligible employees receive medical, dental, and vision insurance, paid time off covering vacation, holidays, and sick leave, a 401(k) plan, and eligibility for long-term incentive programs.
Is the salary for this position specified in the job posting?
The posting does not specify a precise salary amount, though it notes that base pay ranges depend on job grade and geographic location for applicants in locations with pay transparency laws.
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