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Regulatory Toxicologist

Mumbai, MH
Job Code:
  • Manufacturing & Production
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Job Details

Coordinate all aspects of testing projects with 3rd party laboratories including assessment of new data to meet regulatory reporting obligationsSummarize, analyze & interpret test results in preparation for submission to regulatory agencies.Ensure regulatory submission meet Good Laboratory Procedure requirements Interface with worldwide regulatory agencies on technical issues, develop and present responses to their questions and requestsManage and coordinate multiple projects and chemistries with a project-based focus rather than research focusRemain abreast of changes in global testing requirements, both implemented and proposed, send samples, coordinate and ensure follow through withGLP /FDA /EPALiaison with scientists of Agricultural Universities, GLPTest Facilities, FDA,EPA, OECDand other accredited agencies for country specific field trialsSupport operations teams for determination of test requirements, sample preparation & submission procedures for materials & products.Act as technical expert & participate in regulatory agency interactionsEffectively communicate in oral & written form, test requirements, regulatory issues and test deviationsPerform literature searches as appropriate for material submissions.Overall responsibilities include expert toxicology consultation, assistance in report writing, literature searches, data gap analysis, product risk assessments, dossier preparation, customer correspondence, and consulting services for internal businesses.Desired Candidate Profile7 to 12 years of experience in Experience with Global Registration in pesticide, chemical, pharmaceutical or related industry sectorsWell conversant with Good Laboratory Procedure requirements for and ability to communicate with 3rd party laboratories and other accredited agencies independently in US, EECCountries, Middle East, Asia, Africa, CISCountries, Latin America and Eastern Europe.Knowledge of regulatory and data requirements for global agrochemical notification dossiers as well as emerging regulatory initiatives (REACH, ChAMP, Biocide Directive etc)B.Sc / M.Sc / BS / MS / B.E / B Tech / Masters / PhD in Toxicology, Ecotoxicology, Pharmacology, Agriculture, Agrochemicals, Agronomy, BioChemistry, Chemistry, Crop Protection, Ecology, Fertilisers or related biological sciences / engineeringKnowledge of common PC-based software is expected, including word processors, spreadsheets, databases, web browsers, and statistical / mathematical software.Profound English Language Competence is mandatory (expatriate experience is an advantage)
Degree: M.Sc. (Science)

Additional Degree: B.Sc. (Science)

Experience: 7-12


Radiology | Regulatory Affairs
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