Job Description

Job Summary:

The Regulatory Compliance Auditor is responsible for implementing and supporting the Regulatory Compliance Program to ensure facilities, operations, studies, and practices comply with applicable regulations (e.g., FDA, EMEA, NRC, DEA, USDA), internal SOPs, policies, and good documentation practices. This role includes conducting audits, issuing reports, monitoring corrective actions, and supporting inspections.

Key Responsibilities:

• Review procedures for compliance with GxP and internal standards.
• Conduct audits related to GLP studies, including protocols, amendments, study data, and investigator reports (e.g., Toxicokinetic reports).
• Issue electronic audit reports and track follow-up actions.
• Maintain and update audit logs and the GLP Master Schedule.
• Scan and organize study records to support audit and inspection readiness.
• Conduct internal facility audits and support external inspections.
• Provide audit support during corporate and regulatory agency inspections.

Requirements:

• GLP auditing or comparable experience.
• Intermediate understanding of relevant regulatory guidelines.
• Ability to work independently with moderate supervision.
• Strong conflict resolution, negotiation, and organizational skills.
• Effective written and verbal communication skills.

Preferred Qualifications:

• Prior experience with GLP auditing.
• Familiarity with Toxicokinetic or Bioanalytical studies.

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