Sava Healthcare Limited is part of Sava Group, which is esteemed 2003 and headquartered in Pune, India, is an integrated PIC/s and WHO-GMP certified manufacturer and Exporter of one of the widest range of therapeutic products from solid/liquid/external preparation dosage forms.
Post : Executive DRA
MAJOR ACTIVITIES
1. Collection of documents from plant QA, QC, Site RA and R & D and review those documents before filing in dossier.
2. Preparation of product wise database and maintain country wise registration status of the dossiers
3. Compilation of dossier in ACTD/Country Specific format for different non-regulated markets (namely ASEAN, Latin America, FWA, CIS).
4. Preparation of country wise blank formats of Registration Dossiers
5. Review of dossiers and finalization according to the respective guidelines of the Countries and also take into account the queries asked for previous submissions and also include those points to avoid further queries and try to make zero error documents.
6. Preparing applications for COPP by collecting all required documents
7. Co-ordination for Artwork Development
8. Co-ordination for arrangement of Registration and legalization Fees
9. Arrangement of Legalization Documents required for Registration purpose and take follow up from Concerned persons to complete same within stipulated time
10. Planning of dispatches of dossiers and samples ,and after dispatching communicate with concerned clients the courier details and take follow up upto safe delivery of same.
11. Responsible for Query responses received from different regulatory authorities and answer respective queries within bounded Timelines.
Additional Information:
Experience : 4+ Years
Qualification : B.Pharm, M.Pharm
Location : Pune
Industry Type: Pharma/ Healthcare
Functional Area : DRA
End Date : 15th April, 2018
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