Designation Deputy Manager- Regulatory Affairs Desired Profile Regulatory filing of the Human Drug Products (Generics and Innovative Product), specifically for the ICH Region (Viz. Regulated markets, US, EU, Swiss, Turkey, Australia and New Zealand Regulatory filing submission of the ANDAs, MAAs, INDs and PINDs etc. for the drug products. Regulatory guidance, review, filings of ANDAs, MAAs, INDs and PINDs. To act as an interface and coordinator among the internal as well as external counterparts. To ensure compliance and timely submission of ANDAs, MAAs, INDs and PINDs etc. together with the timely submission of the deficiencies responses. Review of the outsourced DMF. Responsible for GDUFA Compliance and firm site registration annually. Assist during international regulatory audits at sites. Supporting the internal stakeholders by providing the regulatory requirements. Responsible for the In-license products Experience 10-14 Years Age 35-45 Years Industry Type Pharmaceutical or Manufacturing Functional Area Regulatory Affairs Education M.Pharma Compensation As per industry norm Department Regulatory Affairs Location New Delhi Contact Panacea Biotec Ltd Email hrd@panaceabiotec; rakheegehani@panaceabiotec Website panaceabiotec/ Job Posted 3rd September2014
Posted on: Sat, 25 Oct 2014 17:16:27 +0000
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