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 : Sr. Executive/ Asst Manager- DRA
Job Description
• Co-ordination with Quality Assurance, Quality Control, R&D and Production depts for technical data required for dossier preparation.
• Good knowledge of ICH, CTD/ ACTD guidelines for registration of drug products.
• Knowledge of Drug product technical parameters- Manufacturing, Analysis, Non-clinical and clinical.
• Good communication skills.
• Regulatory audit exposure.
• Understanding of local FDA/CDSCO licensing.
• Multi tasker when assigned important assignments.
Candidate Profile
M.Pharm / B.Pharm graduates with experience in the drug regulatory affairs functions for the export of finished formulations to the ROW/Semi regulated markets
Additional Information
Experience : 4 to 9 year(s) of Experience
Qualification : M.Pharm / B.Pharm
Location : Pune
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : DRA
End Date : 30th May,2021
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