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

Strong understanding of global regulated documentation standards

Experience with audit management and inspection readiness

Knowledge of CAPAs, deviations, change controls, and risk assessments

Robust analytical, communication, and stakeholder management skills

Use regulatory compliance, inspection readiness, and quality systems expertise to address risks and improve regulated operations across Canada.

📌 GxP Compliance Regulatory Affairs Consultant (Winnipeg)
🏢 Jobgether
📍 Winnipeg