R-opening as Drug Regulatory Affairs Executive

Drug Regulatory Affairs Executive
United Biotech Pvt. Ltd. - Navi Mumbai, Maharashtra

Preparation of Registration Export/ Import dossiers of pharmaceutical formulation for CIS, US European Countries. Liasioning with Government Authorities for regulatory approval. Awareness about CTD Formats and CTD Modules details. Independently handling of all dossiers as per country requirements. Co- ordination with R D, QA / QC for preparation of dossiers. 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.
• Must have experience of Quality Assurance.