Regulatory Officer @ Galentic harma

Job Description

• Preparation of registration Dossier as per Common Technical Documents, and country specific guidelines (FORMULATIONS).
• Filling of questionnaire to participate in international tenders.
• Arranging for Samples of finished product, working standards, reference standards for registration.
• To respond to queries received from various Ministry Of Health and other authorities after submission of dossiers.
• Preparations of all documents required for sample sending to party like invoice, certificate of analysis,packing list, MSDS, declaration letter, non hazardous certificates etc.
• Co-ordinate with quality assurance, Quality control, Analytical development & R& D departments for collecting & reviewing technical documents such as Analytical Method Validation, Process Validation, Stability data, finished product specification, Active & Inactive ingredients Specifications, packing materials specifications, packing material samples.
• Sending documents legalization and notarization for registration.
• Arranging Samples as per registration requirements for different countries.
• Preparation /Review of labelling & Packaging material, packing insert.
• On-line application to FDA for new product permissions, FSC, GMP, NCC, MMC, Performance Certificates, COPP etc. (Training will be given).
• Preparation of documents for domestic tenders.

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Rs 0 - 50K PM Rs 50K - 1 LPA Rs 1.0 - 1.5 LPA Rs 1.5 - 2.0 LPA Rs 2.0 - 2.5 LPA Rs 2.5 - 3.0 LPA Rs 3.0 - 3.5 LPA Rs 3.5 - 4.0 LPA Rs 4.0 - 4.5 LPA Rs 4.5 - 5.0 LPA Rs 5 - 6 LPA Rs 6 - 7 LPA Rs 7 - 8 LPA Rs 8 - 9 LPA Rs 9 - 10 LPA Rs 10 - 12 LPA Rs 12 - 14 LPA Rs 14 - 16 LPA Rs 16 - 18 LPA Rs 18 - 20 LPA Rs 20 - 22 LPA Rs 22 - 24 LPA Rs 24 - 26 LPA Rs 26 - 28 LPA Rs 28 - 30 LPA Rs 30 - 32 LPA Rs 32 - 34 LPA Rs 34 - 36 LPA Rs 36 - 38 LPA Rs 38 - 40 LPA Rs 40 - 42 LPA Rs 42 - 44 LPA Rs 44 - 46 LPA Rs 46 - 48 LPA Rs 48 - 50 LPA Rs 50 - 75 LPA Rs 75 Lakh - 1C PA Rs 1 Crore+ PA

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