Gxp Compliance Regulatory Affairs Consultant

GxP compliance and inspection readiness anchor this fully remote Regulatory Affairs Consultant opportunity in Canada. Strengthen documentation, audits, and quality systems.This consultant provides regulatory and quality guidance within pharmaceutical and biotechnology environments. Responsibilities include risk identification, inspection support, training governance, QMS processes, and compliance monitoring. The role requires collaboration across Regulatory Affairs, Quality, CMC, Clinical Operations, Pharmacovigilance, and Medical Writing.Key Responsibilities:
Identify compliance risks and implement mitigation strategiesSupport FDA, EMA, and MHRA inspections and auditsContribute to remediation plans for inspection observationsMonitor training completion, overdue records, and effectivenessAnalyze compliance trends and recommend corrective actionsRequirements:
At least eight years of pharmaceutical or biotechnology GxP experienceStrong understanding of global regulated documentation standardsExperience with audit management and inspection readinessKnowledge of CAPAs, deviations, change controls, and risk assessmentsStrong analytical, communication, and stakeholder management skillsUse regulatory compliance, inspection readiness, and quality systems expertise to address risks and improve regulated operations across Canada.
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