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Hiring Regulatory Operations Assistant I
🏢 Fortrea
📍 Pune
⏳ 0–1 Years
📑 Regulatory Affairs / CMC
Fortrea is hiring Regulatory Operations Assistant I in Pune. This is an excellent opportunity for freshers to start a career in Regulatory Affairs, CMC documentation, and pharmaceutical lifecycle management.
💡 Strong entry-level opportunity to work on global regulatory submissions (US, EU, Japan).
👉 Career Guide: Career Options After B.Pharm
📋 Key Responsibilities
- Prepare and review CMC regulatory documents
- Support global submissions (US/EU/ROW)
- Handle product lifecycle documentation
- Manage change control & impact assessment
- Assist in stability data & dissolution analysis
- Maintain regulatory records (RIMS systems)
💻 Required Skills
- Basic knowledge of CMC & regulatory documentation
- Understanding of GxP / ICH guidelines
- Strong analytical & documentation skills
- Attention to detail & quality focus
🎓 Eligibility
- B.Pharm / M.Pharm / MSc / Life Sciences
- 0–1 year experience (Freshers eligible)
- Knowledge of pharma lifecycle (preferred)
💡 Interview Tips
- Understand CMC & drug lifecycle
- CDISC Basics
- Aptitude Practice
💰 Salary & Growth
- ₹3.2 – ₹5.5 LPA
- Growth → Regulatory Associate → Senior RA → Manager
- Salary Guide
📌 Apply before 18 April 2026
🚀 Job Application Link
📌 Important Note Before You Apply:
Kindly read the full job description carefully before applying. Ensure your profile aligns with regulatory submissions publishing, electronic document management systems (EDMS), hyperlinking/bookmarking submission dossiers, and global health authority compliance standards (like eCTD formatting) before proceeding.
Kindly read the full job description carefully before applying. Ensure your profile aligns with regulatory submissions publishing, electronic document management systems (EDMS), hyperlinking/bookmarking submission dossiers, and global health authority compliance standards (like eCTD formatting) before proceeding.
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