Title:  Exe / Sr Exe

Date:  Mar 20, 2024
Location:  Tandalja - R&D
Company:  Sun Pharmaceutical Industries Ltd



Position          :    Exe / Sr. Exe   (Regulatory Affairs, Baroda)


Grade              –  G12A/G11B


Education       –    B.Pharm / M. Pharm


Experience       –   4 to 6 years


Location          –    R&D - Baroda


Job Description:

  • Review all data and documents related to product registrations for various health authorities.
  • Compile registration dossiers for submission to various health authorities like – US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.
  • Prepare responses to deficiency letters received from various agencies.
  • Maintain life-cycle / post approval changes for drug product registration dossiers.
  • Provide regulatory support to cross functional departments.
  • Prepare and submit scientific advice to various health authorities.
  • eCTD compilation, verification and submission through electronic gateway