# Regulatory Subject Matter Expert

**Company**: Fortrea
**Location**: Bangalore
**Experience**: senior
**Job type**: full-time
**Category**: Operations
**Industry**: Healthcare

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Bangalore/QA-Compliance-Lead-Auditor--Host-_266463?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_9d86ba28-147

## Description

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.

For more fresh new jobs, check out [yubhub.co](https://yubhub.co/).

## Skills

### Required
- GCP
- regulatory compliance
- audit management
- strategic communication
- risk-based assessment

### Nice to have
- postgraduate degree in scientific or management-related discipline

---

Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Bangalore/QA-Compliance-Lead-Auditor--Host-_266463?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)