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Hiring Regulatory Operations Assistant I
Fortrea
Mumbai
0–3 Years
Regulatory Affairs
Pharma
🏢 About Company
Fortrea is a global clinical research organization (CRO) providing regulatory, clinical, and drug development services to pharmaceutical and biotech companies worldwide.
💼 Job Overview
- Role: Regulatory Operations Assistant I
- Location: Mumbai
- Experience: 0–3 Years
- Qualification: B.Pharm / M.Pharm / Life Sciences
- Job Type: Full-Time
📌 Key Responsibilities
- Prepare and manage regulatory submission documents
- Support global submissions (US FDA, EMA, PMDA)
- Maintain regulatory documentation & EDMS
- Ensure compliance with GxP & ICH guidelines
- Coordinate with cross-functional teams
- Support analytical & quality documentation
🎓 Eligibility
- B.Pharm / M.Pharm / Life Sciences
- 0–3 years experience
- Knowledge of Regulatory Affairs preferred
💻 Required Skills
- GxP & ICH guidelines knowledge
- Regulatory documentation
- Analytical thinking
- MS Office proficiency
- Communication skills
💰 Salary
- ₹4 – ₹7 LPA (Estimated)
🎯 Interview Tips
- Revise GxP & ICH guidelines
- Understand CTD/eCTD structure
- Learn basics of regulatory submissions
- Know drug development lifecycle
- Prepare pharma documentation questions
📚 Helpful Resources:
📌 Note Before You Apply:
Kindly read the entire job description carefully before applying. Make sure your qualifications align with the role.
Kindly read the entire job description carefully before applying. Make sure your qualifications align with the role.
🚀 Job Application Link
🔒 Regulatory Operations Guide:
Fortrea's regulatory teams look for individuals with high attention to detail in document lifecycle management. Before submitting your profile on their Workday network, ensure your resume highlights foundational knowledge of global health authority submission formats, eCTD document formatting standards, quality check processes, and electronic archive maintenance.
Fortrea's regulatory teams look for individuals with high attention to detail in document lifecycle management. Before submitting your profile on their Workday network, ensure your resume highlights foundational knowledge of global health authority submission formats, eCTD document formatting standards, quality check processes, and electronic archive maintenance.
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