Corona Remedies Hiring For RA Dept
Regulatory Affairs (Officer/Sr.Officer/Executive)
Qualification: B.Pharm/M.Pharm
Experience: 3-5 Years
Responsibilities
• Must have complete knowledge of dossier filling from start to finish as per EU.
• Literature search for development phase of drug product.
• Day to Day communication with Different Departments of the Plant as well as client/agents for submission of dossier in a timely manner.
• Has understanding of all regulatory pathways for EU Submissions (i.e. Mutual Recognition Procedure, Decentralized, Centralized Procedure etc.) and can compile EU eCTD dossier.
• Management of Regulatory Database, Product Life cycle and review of commercial documents.
• Identify variation categories for post-approval activities and compilation, review and submission of variation in a timely manner.
• Should have a good knowledge of labelling requirements in European countries.
Interested candidate can apply through QR code scan
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Corona Remedies Hiring For RA Dept |
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