Regulatory Affairs Trainee
5 days ago
Job Purpose:
To assist the Regulatory Affairs team in day-to-day activities related to CDSCO, ONDL and State FDA submissions, documentation, and compliance.
Key Responsibilities:
Submissions & Coordination
Preparation and submission of applications to CDSCO, ONDL and State FDA for:
Export NOC Application of Banned & Unapproved products
- Product Permission Application
- Free Sale Certificate Application
- Form-29 Application
- COPP Application
- Uploading old licensing data on ONDL portal
- CT-11 Application
Documentation & Record Keeping
- Maintain updated files for approvals
- Ensure proper archiving of all approvals
System & Portal Management
- Learn and support in operations on Sugam / ONDL / NSWS / XLN/ WHO-GMP/GRAS and other online submission systems.
Skills & Attributes:
- Basic understanding of CDSCO, FDA
- Good communication and coordination skills.
- Attention to detail, documentation accuracy, and willingness to learn.
- Proficient in MS Office (Word, Excel, PDF handling).
Qualifications
Essential: B.SC / B. Pharm with 1-2-year experience
Languages Known: English is Mandatory
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