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Senior Executive - Regulatory Affairs @ Godrej Industries

New Delhi, Delhi, INOnsiteFull-time
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About this role

Job Requirements

Role Purpose

To manage data generation, preparation & data compilation of Bio-efficacy, Phytotoxicity, Residue & Persistence from various SAU’s, ICAR Institutes & CRO’s as per Guidelines approved by CIB&RC.

Bio-efficacy data generation for application for registration u/s 9(3) TI-NS, FIM, TIM, TI, FI & Label Expansions/Endorsements. In addition to this Bio-efficacy data generation for the application for inclusions in FCO (Fertiliser Control Order).

The role enables data generation, preparation & data compilation from Bio-efficacy, Phytotoxicity, Residue & Persistence part in an application for registration.

Roles & Responsibilities

Data generation, preparation & data compilation Bio-efficacy part for registration of products u/s 9(3) TI-NS, FIM, TIM, TI, FI & Label Expansion products in portfolio including:

  • Check all the parameters of Product Profile received from R&D & Protocol preparation (Per product per crop) & Finalization of Protocol.
  • Identification of SAU's in accordance with Crops & call the Quotations for data generation.
  • Preparation of Comparison sheets from various SAU’s & CRO’s for further allotment of project.
  • Managing sample & Payment release along with documents for study initiation to SAU’s & CRO’s in coordination with Finance & R&D.
  • Payment details intimation/Letter to SAUs & CRO’s & Request invoice for further settlement of amount.
  • Arrangement of residue and persistence samples along with Sample letters from SAU’s.
  • Review & Finalization of draft Study Report as per/in line for registration in CIB&RC guidelines/requirements.
  • Preparation & Compilation of Bio-efficacy, Residue, Persistence & Label/Leaflet Folder of an application along with Proforma finalized by CIB&RC.
  • Preparation for Deficiency reply to CIB&RC – Bio-efficacy Part
  • Preparation/Compilation of Bio-efficacy Part in MRL Proforma
  • Preparation & Compilation of relevant Bio-efficacy Endorsement in CIB&RC - CROP Portal.
  • Visit to SAU’s whenever required.

Work Experience

4-6 years

Skills

regulatory compliancebio-efficacy data generationregulatory registration applicationsphytotoxicity data generationresidue data compilationpersistence data compilationprotocol preparationregulatory affairsstudy report reviewsample managementpayment settlementcro coordinationsau coordinationlabel endorsement preparationdeficiency reply preparation

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