A Regulatory Affairs Manager plans, directs, or coordinates production activities of an organization to ensure compliance with regulations and standard operating procedures.
Regulatory Affairs Associate Katalyst Healthcares & Life Sciences - 4.0 North Chicago, IL Job Details Contract 1 day ago Qualifications Bachelor's degree Regulatory readiness in healthcare Cross-functional collaboration Project stakeholder communication Stakeholder relationship building Cross-functional communication Audit support Stakeholder management
Full Job Description Summary:
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 Client 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.
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.
