Regulatory Affairs Trainee

1 - 2 years

2 - 3 Lacs

Posted:1 day ago| Platform: Naukri logo

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Work Mode

Work from Office

Job Type

Full Time

Job Description

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:

  1. 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

Languages Known:

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