MANAGER, PROCESS EXCELLENCE - REGULATORY AFFAIRS

Manager, Process Excellence - Regulatory Affairs Location: North Chicago, Illinois Category: Regulatory Affairs Salary: Apply for details Country: United States Employment: Contract Worksite: On-Site Target PR Range: 20-30/hr Job Description The 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. Key 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 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. Qualifications 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: 5+ 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 Equal Opportunity Employer We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements. #J-18808-Ljbffr Planet Pharma