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. #J-18808-Ljbffr The Fountain Group