Regulatory Affairs Associate III

Hyrid, North Chicago (onsite Tues, Wed, Thurs)

Pay: $65-$70/hr

Required:

Required Skills & Qualifications

• Bachelor's degree in a Life Sciences discipline, such as Pharmacy, Biology, Chemistry, Pharmacology, or a related field.
• 5+ years of experience within Regulatory Affairs, pharmaceutical, biotechnology, medical device, Quality, or a related regulated environment.
• Experience with issue management, CAPA, deviations, investigations, exception reporting, or comparable compliance workflows.
• Experience performing or supporting root cause analysis and corrective/preventive action activities.
• Experience with Quality Management Systems (QMS) and controlled compliance processes.
• Experience supporting internal/external audits, regulatory inspections, and inspection readiness.
• Experience with change control/change management and implementation of business process changes.
• Ability to assess and triage compliance or process issues based on risk, severity, and business/regulatory impact.
• Strong project management and process improvement capabilities with the ability to manage multiple issues, projects, and priorities simultaneously.
• Demonstrated ability to collaborate with Regulatory Affairs, Quality, Business Process Owners, and other cross-functional stakeholders.
• Strong organizational, analytical, facilitation, written, and verbal communication skills.
• Ability to influence without direct authority and work effectively within a highly matrixed organization.

Preferred: Experience with RAIM, OneTrack, TrackWise, Veeva Vault, CAPA/issue management systems, Regulatory Affairs business processes, legacy-company integrations, process excellence, or continuous improvement. An advanced degree in science or business and/or relevant professional certification is a plus.

Job Description

The Manager, Process Excellence will support compliant, efficient, and inspection-ready Regulatory Affairs operations by managing issue/CAPA processes and driving cross-functional process improvements.

Key responsibilities include:

• Manage the Regulatory Affairs Issue and CAPA Management (RAIM) system, ensuring issues are properly documented, assessed, tracked, and resolved.
• Triage Regulatory Affairs issue records to determine severity, compliance impact, risk, and appropriate next steps.
• Determine when issues require escalation to Exception Reports based on significance and potential regulatory or process impact.
• Project manage Exception Reports from initiation through resolution, partnering with stakeholders to conduct root cause analysis, establish corrective actions, and prevent recurrence.
• Track actions, deliverables, owners, and timelines to ensure timely closure of issues and CAPAs.
• Partner with Regulatory Affairs leadership, Business Process Owners, Quality, and other functions to resolve compliance and process issues.
• Support internal and external audits and regulatory inspections, including documentation coordination, issue follow-up, and inspection-response activities.
• Manage change plans in OneTrack associated with integration of legacy companies into established Regulatory Affairs business processes.
• Support implementation and adoption of new or revised Regulatory Affairs processes.
• Maintain accurate and inspection-ready issue records, CAPA documentation, Exception Reports, process documentation, and change plans.
• Identify recurring issues, process gaps, and improvement opportunities and work cross-functionally to implement sustainable solutions.
• Communicate issue status, risks, corrective actions, and process changes effectively to stakeholders across multiple functions and organizational levels.