Regulatory Affairs Associate III

Location: North Chicago, Illinois • Contract • 9 to 5

About the role

The Manager, Process Excellence within Regulatory Affairs manages 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, 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 records are appropriately logged, tracked, and resolved.
• Triage RAIM issue records to determine severity, compliance impact, and necessary next steps.
• Escalate issue records to Exception Reports based on risk and process significance.
• Project manage Exception Reports in partnership with cross-functional stakeholders to identify root causes and drive corrective actions.
• Collaborate with Regulatory leaders, Business Process Owners, and Quality teams to ensure timely issue management.
• Support internal/external audit and inspection readiness, including documentation coordination and response support.
• Manage legacy integrations for business processes through structured change plans in OneTrack.

Requirements

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology, or related field).
• 5+ years of experience in regulatory, pharmaceutical, or medical device environments.
• Hands-on experience managing issue/CAPA systems, exception reporting, or compliance investigation workflows.
• Strong organizational, analytical, communication, facilitation, and stakeholder management abilities.
• Proven ability to manage multiple priorities and influence without authority in a matrixed environment.

Preferred Qualifications

• Relevant advanced degree in science or business, or industry certifications.
• Background in Regulatory Affairs, Quality, process excellence, or business process management.
• Experience supporting audit and inspection readiness in a regulated environment.
• Proficiency managing process integrations using change platforms like OneTrack.

Skills

• Regulatory Affairs Operations
• Corrective and Preventive Actions (CAPA)
• Regulatory Information Management (RIM)

Pay

$60.00 - $68.34 per hour

Benefits

• Medical, prescription, dental, and vision insurance
• AD&D and life insurance
• Short-term disability
• 401K plan