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 strategies
Support FDA, EMA, and MHRA inspections and audits
Contribute to remediation plans for inspection observations
Monitor training completion, overdue records, and effectiveness
Analyze compliance trends and recommend corrective actions
Requirements: At least eight years of pharmaceutical or biotechnology GxP experience
Robust understanding of global regulated documentation standards
Experience with audit management and inspection readiness
Knowledge of CAPAs, deviations, change controls, and risk assessments
Strong analytical, communication, and stakeholder management skills
Use regulatory compliance, inspection readiness, and quality systems expertise to address risks and improve regulated operations across Canada.