Assistant Manager /Sr. Executive – Regulatory Affairs

3 - 6 Years
INR 2,50,000 - 6,00,000 PA.
Posted: 8 days agoOpenings: 1Job Applicants: 325Job Views: 720

Job Description

  1. Review the GLP chemistry reports ( Phys-Chem report, 5-Batch report)
  2. Preparation of new in-house Non-GLP reports (Phys-Chem report, QC report, 5-Batch report with method validation)
  3. Prepare the dossiers documents for the products to submit in different countries (Paraguay, Uruguay, Iran, Brazil, Malaysia, Turkey, Taiwan, Korea) and reply to queries related to that countries
  4. Search chemical reaction & synthesis route of different product by database search from Sci-Finder
  5. Analysis of technical product to find out its impurity profile with name and concentration of impurities.
  6. Identification of Impurities with the help of NMR & Mass spectra.
  7. Preparation of MSDS, TDS & Technical Bulletin of different product for different country
  8. ADI and Classification of compound according to International Organization (FAO, WHO, EPA, EU)
  9. Ask quotation for new data generation & custom synthesis of impurities from different lab.
  10. Prepared Toxicity Summary
  11. Product Specification & composition
  12. Labels & leaflet
  13. Database Search (Sci-Finder, Toxnet, Extoxnet, Pubchem, Inchem, FAO, EPA, CDPR, ECHA, CODEX, NPIC, Pubmed )
  14. Legalisation of documents for different countries
  15. Data form of hazardous material
**Candidate with experience in Agrochemical industry need to Apply Only. 

Required Candidate profile

  1. Knowledge of Pesticide reactions and chemistry studies and analysis calculations.
  2. Experience of overseas regulatory dossier preparation. 
  3. Understanding of chemical and Toxicological properties and applications of the pesticides products. 
  4. Review to comments the GLP test reports of physico-chemical properties and toxicity. 
  5. Lab/R&D experience in industry will be preferred. 

Salary: INR 2,50,000 - 6,00,000 PA.

Industry:Fertilizers / Pesticides

Functional Area:Engineering Design, R&D

Role Category:Drug Regulatory Affairs/Documentation

Role:Regulatory Affairs Manager

Employment Type:Full Time, Permanent


Desired Candidate Profile

Please refer to the Job description above


UG:B.Sc - Chemistry

PG:MS/M.Sc(Science) - Organic Chemistry

Company Profile


A flagship company engaged in the manufacturing of Technical Grade Pesticides and Intermediates confirming to International Standards.
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Recruiter Name:HR Dept