Regulatory Documents Assistant Job – Forever at Indero CRO
Company: Indero CRO
Role: Regulatory Documents Assistant
Location: Delhi (Remote/Office-Based – India)
Experience: 0 – 1 Year (Freshers welcome)
Qualification: B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Life Sciences
Job Type: Full-Time, Permanent
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About Indero CRO:
Indero is a specialized CRO focused on dermatology and rheumatology clinical trials. Established in 2000, Indero is known for delivering high-quality research with a global reach across North America and Europe.
Job Description:
As a Regulatory Documents Assistant, you will support critical regulatory documentation tasks to ensure compliance with ICH-GCP and company SOPs.
Key Responsibilities:
- ✔ Set up and maintain Trial Master File (TMF), both electronic and paper
- ✔ Perform document quality checks and reviews
- ✔ Assist in eTMF metadata tracking and quality audits
- ✔ Verify site regulatory documents for completeness and accuracy
- ✔ Collaborate with CRAs and project teams to resolve TMF queries
- ✔ Support administrative tasks including shipment coordination and tracking
Eligibility & Requirements:
- ✅ Bachelor’s/Master’s in Life Sciences, Pharmacy, or related field
- ✅ Knowledge of clinical research documentation
- ✅ Basic familiarity with pharma/CRO environments (preferred)
- ✅ Proficiency in MS Word & Excel
- ✅ Strong organizational skills and attention to detail
- ✅ Good English communication; French is a bonus
Why Join Indero?
- ✨ Flexible work arrangements
- ✨ Permanent full-time role
- ✨ Comprehensive benefits (health, insurance)
- ✨ Ongoing training & development
- ✨ Supportive and innovative workplace
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