Job Description

When our values align, there's no limit to what we can achieve.
 

  • 4-7 yrs in-depth knowledge of Indian regulatory guidelines for clinical trials, including NDCT Rules.
  • Hands-on experience with SUGAM portal for Initial Clinical Trial Application (CTA/iCTA) submissions and amendments.
  • Ability to liaise effectively with global sponsors and cross-functional teams.
  • Prepare necessary documentation, presentations, and briefing materials for SEC meetings
  • Strong understanding of global regulatory expectations and harmonization with Indian requirements.
  • Acquired hands-on expertise in managing and completing clinical trial registrations on the Clinical Trials Registry-India (CTRI) portal.
  • Updated with current Guidelines and Gazette Notifications to give suggestions/comments to respective Regulatory authorities and Govt. regulatory bodies.
  • Working knowledge of India regulatory procedures i...

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