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Opening in Drug Regulatory Affairs – US Group
Job Location: Baroda
Grade: Executive / Sr Executive
Qualification: M.Pharm
Job Description:
1) Review all data and documents related to product registrations for various health authorities.
2) Compile registration dossiers for submission to various health authorities like – US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.
3) Prepare responses to deficiency letters received from various agencies.
4) Maintain life-cycle / post approval changes for drug product registration dossiers.
5) Provide regulatory support to cross functional departments.
6) Prepare and submit scientific advice to various health authorities.
7) eCTD compilation, verification and submission through electronic gateway

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Freshers need not apply.

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