Hiring Regulatory Operations Assistant I
🏢 About Fortrea
Fortrea is a global contract research organization supporting pharmaceutical and biotechnology companies in drug development, clinical trials, and regulatory submissions. The company provides regulatory operations support for global health authorities including the US FDA, EMA, PMDA Japan, and other international agencies.
📌 Job Overview
- Position: Regulatory Operations Assistant I
- Company: Fortrea
- Location: Mumbai, India
- Experience: 0–3 Years
- Qualification: B.Pharm / M.Pharm / Life Sciences
- Job Type: Full-Time
- Application Deadline: 10 March 2026
🔬 Key Responsibilities
- Prepare and compile regulatory submission documents
- Support submissions to US FDA, EMA, Japan PMDA and other global authorities
- Maintain regulatory documentation and specifications
- Ensure compliance with GMP, GLP, GDP and ICH guidelines
- Support regulatory document review and quality checks
- Manage electronic document management systems (EDMS)
- Coordinate submission activities with cross-functional teams
- Maintain training documentation and regulatory records
🧪 Analytical & Technical Exposure
- API and finished product assay analysis
- Impurity and related substances testing
- Residual solvent and dissolution testing
- Content and blend uniformity studies
- Process validation and cleaning validation documentation
Common instruments used: HPLC, UPLC, Gas Chromatography, Karl Fischer, Dissolution apparatus, Particle size analyzer.
🎓 Required Qualifications
- B.Pharm / M.Pharm
- Life Sciences degree
- Knowledge of pharmaceutical product lifecycle
- Understanding of GxP and regulatory guidelines
- Strong documentation and analytical skills
- Microsoft Office proficiency
💰 Estimated Salary
₹4,00,000 – ₹7,00,000 per year (Approximate range based on industry benchmarks)
⭐ Why Join Fortrea?
- Exposure to global regulatory submissions
- Experience with international health authorities
- Career growth in regulatory affairs and drug development
- Collaborative global clinical research environment
🎯 Interview Preparation Tips
If you are preparing for Regulatory Affairs or Clinical Research roles, reviewing common interview questions and career guides can help strengthen your preparation.
👉 Explore helpful resources here:
Clinical Research & Regulatory Affairs Career Guides
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