Fortrea is a leading global contract research organization (CRO) that partners with biopharmaceutical and medical device companies to deliver innovative solutions in clinical development and commercialization. With a strong commitment to quality and compliance, Fortrea provides end-to-end support in drug development, regulatory affairs, and product lifecycle management.
Current Job Openings at Fortrea Mumbai
Fortrea is hiring for two critical roles in Mumbai:
- Regulatory Operations Principal Specialist
- Regulatory Operations Associate II
Both positions offer exciting opportunities to work in a dynamic regulatory and compliance environment.
1. Regulatory Operations Principal Specialist – Job Details
Job ID: 252258
Location: Mumbai
Job Type: Full-time
Last Date to Apply: May 17, 2025 (4 days left)
Job Description
The Regulatory Operations Principal Specialist will support the Product Quality Management (PQM) team with a focus on compliance, risk management, and technical documentation.
Key Responsibilities:
- Prepare and deliver technical reports in compliance with cGMP standards.
- Support risk management processes and documentation for quality assurance.
- Provide quality oversight for combination product development and lifecycle management.
- Collaborate with stakeholders to identify improvement opportunities and meet compliance goals.
- Conduct risk assessments and develop mitigation plans, including CAPA (Corrective and Preventive Action) initiatives.
- Ensure adherence to Standard Operating Procedures (SOPs) and regulatory requirements.
- Manage documents in the document management system (DMS).
- Troubleshoot issues and provide solutions for technical documentation challenges.
Education & Experience
- Bachelor’s/Master’s degree in Pharmacy, Biotechnology, Life Sciences, or related field.
- 5+ years of experience in regulatory affairs, quality assurance, or pharmaceutical compliance.
- Strong knowledge of cGMP, FDA/EMA regulations, and risk management.
- Experience with document management systems (DMS) and CAPA processes.
2. Regulatory Operations Associate II – Job Details
Job ID: 252255
Location: Mumbai
Job Type: Full-time
Last Date to Apply: May 17, 2025 (4 days left)
Job Description
The Regulatory Operations Associate II will support the Chemical and Pharmaceutical Development & Supply (CPDS) team with training management, electronic lab systems, and compliance activities.
Key Responsibilities:
- Training Management: Maintain training curricula, track compliance, and manage ComplianceWire (CW) training modules.
- Electronic Lab Notebook (ELN) Support: Validate spreadsheets, review user access, and manage templates.
- Document Handling: Manage controlled prints, upload documents in Tru-Vault Docs, and route SOPs/WIs for approvals.
- System Upgrades: Support Windows 10 migration, RIMS 5, and Project Olympus implementations.
- Computerized System Validation (CSV): Ensure compliance with validation protocols.
- Scientific Systems Support: Work with Deskman, FR5, OpenLab, Empower, and other compliance tools.
Education & Experience
- Bachelor’s/Master’s degree in Pharmacy, Chemistry, Biotechnology, or related field.
- 2-4 years of experience in regulatory operations, compliance, or lab support roles.
- Experience with ELN, ComplianceWire, and CSV is preferred.
- Knowledge of GMP/GLP regulations is a plus.
How to Apply
Application Link For Regulatory Operations Principal Specialist
Application Link For Regulatory Operations Associate II
