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Preparation of Registration & Export/ Import dossiers of pharmaceutical formulation for CIS, US & European Countries. |
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Liasioning with Government Authorities for regulatory approval. |
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Awareness about CTD Formats and CTD Modules details. |
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Independently handling of all dossiers as per country requirements. |
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Co- ordination with R & D, QA / QC for preparation of dossiers. |
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To conduct experimental analysis for the assigned project/s, required to study, develop new formulations / products for Regulated market, and assist in scaling-up and technology transfer. |
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Must have experience of Quality Assurance. |
