Senior Manager, Regulatory Affairs Process Excellence

Role: Senior Manager, Process Excellence in Regulatory Affairs, focusing on managing issue and CAPA activities to ensure compliant, efficient, and inspection-ready operations. Responsibilities: oversee the Regulatory Affairs Issue and CAPA Management system (RAIM), triage issue records, escalate significant issues through Exception Reports, and lead cross-functional projects to identify root causes and implement corrective actions; support audit and inspection readiness, manage change plans during legacy integrations, and maintain process documentation and communication. Requirements: Bachelor's degree in life sciences; 8+ years in regulatory, pharmaceutical, or device industries, with experience in regulatory affairs, quality, or process management; proficiency in issue/CAPA systems, compliance workflows, and audit support; strong organizational, analytical, stakeholder management, and communication skills; ability to influence in a matrix environment. High-Value: experience in regulated environment compliance, issue management, and process improvement within pharma or biotech; knowledge of regulatory processes and inspection readiness. WorkSetup: hybrid (3 days in-office, 2 days remote) at Lake County, IL; no travel specified.