Prepare, compile, review, and submit product registration dossiers in CTD I eCTD format as per country-specific requirements and EAEU Unified Registration Procedure.
Evaluation of regulatory documents, compilation of dossier and submissions to CDSCO-HQ/CDSCO-Zonal offices for regulatory approval of drug substance and drug products.
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
Completion of designated projects and tasks supporting European Market RA and International Market RA, according to internal Work Instructions, with guidance and direction by the manager and more senior colleagues.
Post Graduate Degree from a recognized University Pharmacy/Regulatory affairs/Biomedical Science/ Medical Devices/ Biomedical Technology. Indian Pharmacopoeia Commission, IPC, an Autonomous organization under the Ministry of Health & Family Welfare
Responsible and Accountable for Preparation / Compilation of registration, re-registration dossier and variation application as per registration guidelines for various countries.