Contributes to the development and implementation of regulatory strategy for assigned region as a member of the Global Regulatory Affairs functional team
Expected M.Pharm by education with 3+ years experience for Document requisition and review, Dossier Preparation, CTD, ACTD, Country specific for ROW Market
Evaluation of regulatory documents, compilation of dossier and submissions to CDSCO-HQ/CDSCO-Zonal offices for regulatory approval of drug substance and drug products.
Adequate understanding on respective authority guidance and filing of new product and post approval changes. Review of documents related to product registration and dossier submission leading to faster approval
Aneta Pharmaceuticals was established in 2023 as a private company that makes medicines, with a production facility approved by the WHO GMP and the Republic of Uzbekistan, and strict quality control that meets GLP standards. The path of success lies in its belief in creativity and no negotiation with the quality of work.
Opening at Aneta Pharmaceutical Pvt. Ltd. For Below Positions at OSD formulation facility
M.Pharm / B.Pharm ; Experience in document review (Regulatory/AQA/R&D), strong knowledge of ICH, EMA, USFDA, WHO guidelines, and good analytical, communication, and coordination skills.