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

 

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