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Opportunity for M.Pharm, B.Pharm in Drug Regulatory Affairs at Sava Healthcare Limited

Opportunity for M.Pharm, B.Pharm in Drug Regulatory Affairs at Sava Healthcare Limited

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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