Title:  Exe / Sr Exe

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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