Job for M.Pharm, B.Pharm, M.Sc in Regulatory Affair at Coral Drugs
Post : Asst.Manager/Sr. Executive: Regulatory Affair
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Job Description:
• Prepare and review regulatory submission for regulated, Semi regulated and row markets.
• Drafting and Compilation of documents for preparation of dossiers and handling related queries.
• Hands on experience of CTD, ACTD and country specific dossiers.
• Responding to queries within scheduled timelines.
• Co-ordination and follow ups with all functional departments.
• Review of pharmaceuticals Development Report (PDR), Manufacturing and validation documents, (QSD) Quality Standard Documents, (COA) Certificate of Analysis.
• Experienced in API Drug Master File creation and filings in regulatory and non-regulatory markets.
Additional Information:
Experience: 3-5 years
Location: Sonipat
Education: M.Sc. /B.Pharm/M. Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Send your application to hrd@coraldrugs.com
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