Jr. Executive International Regulatory Affairs at Baxter International Inc.
About
鈥� Preparation and review of the dossiers as per the current prescribed guidelines of the respective regulatory authorities.
鈥� Provided regulatory guidance and expedite responses to regulatory authorities. Ensure documentation complies with regulations for international submissions.
鈥� Review of the quality and analytical data as per the pharmacopoeia, specification, MOA, STP, Batch records, Stability, Finished product / Packaging material data for the purpose of compilation of the dossier.
鈥� Review of documents required for regulatory agencies (Viz. Analytical reports, Process Validation Report, Process Validation Protocol, Master Formula Record, Batch Manufacturing Record, Pharmaceutical...
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