Fortrea Regulatory Operations Specialist I Jobs

Fortrea Regulatory Operations Specialist I Jobs – Mumbai

Fortrea is hiring a Regulatory Operations Specialist I for its team in Mumbai, Maharashtra. This opportunity is suited to candidates with a scientific background in pharmaceutical, chemical, or biological sciences and 5–7 years of experience in the pharmaceutical industry, preferably in Quality Assurance. The role involves regulatory operations, document review and approval, quality issue management, CAPA, change controls, risk assessment, and compliance with client requirements. Candidates with relevant industry experience can apply through the official Fortrea careers portal.

Company Overview

Fortrea is a global contract research organization (CRO) that supports pharmaceutical and biotechnology companies in clinical development and related services. This position involves regulatory operations and quality-related responsibilities, including coordination with internal teams, clients, and business partners.

Job Details

• Company: Fortrea

• Designation: Regulatory Operations Specialist I

• Job Requisition ID: 265581

• Location: Mumbai, Maharashtra

• Employment Type: Full-time

• Work Environment: Office or remote

• Experience: 5–7 years in the pharmaceutical industry, preferably in Quality Assurance

• Application Deadline: October 17, 2026

Job Role & Responsibilities

The selected candidate will support regulatory operations, quality management, project coordination, and compliance activities.

Regulatory Operations & Document Management

• Review and approve documents, including protocols and reports related to method qualification, method validation, method transfer, investigations, and non-conformances.

• Coordinate regulatory operations involving the creation, revision, compilation, and approval of specifications, regulatory documents, and labeling documents across the product lifecycle.

• Support regulatory submissions to health authorities in the United States, European Union, Japan, and other regions, as applicable.

• Coordinate with supported departments and project teams to maintain service quality and meet agreed timelines.

Quality Assurance & Compliance

• Handle quality issues, Corrective and Preventive Actions (CAPA), and change controls related to clients and their contract laboratories.

• Support continuous improvement in quality culture and contribute to achieving Quality Key Performance Indicators (KPIs).

• Participate in relevant meetings, including Quality Assurance CSQ meetings, CAPA board meetings, quality improvement programs, and business connect meetings.

• Ensure compliance with procedures, quality standards, and customer requirements.

Risk Assessment & Stakeholder Management

• Collaborate on data-driven risk assessments, including risk identification, analysis, and evaluation.

• Develop risk mitigation plans and support CAPA initiatives.

• Build effective working relationships with stakeholders and business partners to identify improvement opportunities and meet business objectives.

• Identify potential issues, troubleshoot problems, resolve conflicts, and recommend appropriate solutions.

Eligibility & Qualifications

Candidates should meet the following minimum requirements:

• Educational Qualification: Bachelor’s or Master’s degree in a scientific discipline, such as pharmaceutical, chemical, or biological sciences, or equivalent experience.

• Experience: 5–7 years of experience in the pharmaceutical industry, preferably in the Quality Assurance department.

• Technical Knowledge: Familiarity with quality documentation, method validation, investigations, non-conformances, CAPA, and change controls is relevant to the listed responsibilities.

• Core Skills: Risk assessment, troubleshooting, stakeholder coordination, quality compliance, and continuous improvement.

Location & Work Environment

The position is listed for Mumbai, Maharashtra, with the work environment described as an office or remote setting. Candidates should confirm the applicable work arrangement with Fortrea during recruitment.

How to Apply

Interested and eligible candidates can submit their applications through the official Fortrea careers website.

Apply Online: Fortrea Regulatory Operations Specialist I – Official Application

Application deadline: October 17, 2026. Apply before the closing date.

Job Summary