Regulatory Subject Matter Expert

This position is within Fortrea's Global Quality Assurance organisation.

You will serve as a regulatory subject matter expert (SME), supporting internal teams, clients, and regulatory authority interactions to ensure ongoing compliance and inspection readiness.

Key Responsibilities:

• Coordinate and host business development, sponsor qualification, routine sponsor audits, regulatory inspections, and for-cause audit activities.
• Serve as a primary point of contact for external auditors, sponsors, inspectors, internal stakeholders, and operational teams throughout the audit or inspection lifecycle.
• Support operational team readiness before, during, and after external audits and inspections.
• Facilitate audit and inspection activities as host, support, or coordinator.
• Manage receipt, triage, review, and internal routing of external audit reports.
• Review and challenge external audit responses, corrective actions, and CAPAs.
• Track external audit commitments, responses, CAPAs, evidence, and follow-up actions.
• Support regulatory inspection readiness and for-cause audit coordination.
• Assist with cross-training, mentoring, coaching, and/or supervision of auditors, audit hosts, or audit support staff.
• Maintain professional and technical knowledge through continuing education.
• Contribute to the development and interpretation of global QA policies related to regulatory requirements.
• Conduct internal audits as directed.
• Perform other related duties as assigned.

Minimum Qualifications:

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Fluent in English, written and verbal.

Required Experience:

• Minimum 8 years of experience in a regulated environment, including GxP roles.
• Demonstrated regulatory expertise with detailed knowledge of GCP and applicable global regulations.
• Experienced Lead GCP Auditor with strong critical thinking and risk-based assessment skills.
• Strong strategic communication skills with clients and internal stakeholders.
• Experience leading or contributing to quality and process improvement initiatives.

Preferred Qualifications Include:

• Postgraduate degree (MSc or equivalent) in a scientific or management-related discipline.

Work Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.