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Subodh Kumar is a seasoned regulatory affairs professional with 20+ years of experience in product registration, global compliance, and data generation. He has a strong background in toxicology, agrochemicals, and hazard communication. Subodh has worked with top companies including Sumitomo Chemical India Ltd, GHARDA CHEMICALS LIMITED, BASF, and Tagros chemicals india (p) ltd.

Experience

  • Sumitomo Chemical India Ltd
    • Mumbai, Maharashtra, India
    • Head-International Registration & Regulatory Affairs
      • Sep 2021 - Present
      • Mumbai, Maharashtra, India

      •Heading International Registration & registering products in Brazil, LATAM, US EPA, Europe, Australia, Asia & African countries •Collaborating with Sumitomo Chemical global team & registration consultants for product registration •Preparing registration budget for the organization keeping in view of organizational plans•Coordinating with CRO’s for timely generation of GLP data •Guiding the team for registration dossiers preparation & timely submission to the regulatory authorities•Actively collaborating with Marketing team and Management for new product registration, GLP data generation and budget•Conduct timely goal-setting, monitoring, review of performance and feedback discussions for team members

  • GHARDA CHEMICALS LIMITED
    • Mumbai Area, India
    • Senior Manager-Registration & Regulatory Affairs
      • Sep 2016 - Sep 2021
      • Mumbai Area, India

      •Product registration in Europe, Argentina, Brazil, USA and other Latin & Asian countries •Project lead for approval of Public Health products from WHO/FAO & PQT-Vector Control (Diflubenzuron, Alpha-cypermethrin 6% SC, Alpha-cypermethrin 10% SC & Temephos 50% EC)•Chlorpyrifos & Quinalphos product defence in India and Chlorpyrifos with JMPR & POP Stockholm Convention •Registration of Dicamba technical, Dicamba 48% SL, Pyraclostrobin 10% + Thiafluzamide 10% SC, Azoxystrobin 10% + Fipronil 5% SC, Azoxystrobin 20% + Thifluzamide 15% SC u/s 9(3) in India•Coordinating with Agricultural University/Institutes & product development team for timely initiation and generation of bio-efficacy and residues data•Coordinating with CRO’s for timely generation of Regulatory data•Coordinating with marketing and development team for regulatory trial protocol inputs/ business case•Discovering the scope of use of existing molecules by identifying new formulations, combinations & label expansions •Regulatory Technical Committee member of CCFI & PMFAI

  • BASF
    • Mumbai Metropolitan Region
    • Registration & Regulatory Affairs-Lead
      • Apr 2014 - Aug 2016
      • Mumbai Metropolitan Region

      •Registration of new products/Label Expansion in India•Prepared responses to the deficiencies issued by Central Insecticide Board & Registration Committee (CIB&RC) on various applications including MRL Proforma•Coordinated with CRO’s (IIBAT & Ross Life Science) for timely generation of chemistry, residues, persistence and packaging data•Played a key role with Agricultural University/Institutes & Product Development Team for timely initiation and generation of bio-efficacy and residues data

  • M/S HEMANI INDUSTRIES LTD
    • Mumbai, Maharashtra, India
    • Senior Manager-Registration
      • Aug 2012 - Apr 2014
      • Mumbai, Maharashtra, India

      •Acted as a Group Leader of Regulatory Team & registered technical & formulated pesticide products in overseas countries (Brazil, Mexico, China, Europe, Australia).•Led and monitored various GLP studies e.g. 5-batch analysis, physio-chemical properties, toxicity & Eco-toxicity; data generated as per (EC) No. 440/2008, US OCSPP & OECD•Prepared technical information on Labels, Safety Data Sheets (SDS) as per (EU) No 453/2010 & 1272/2008 (CLP), Product specification etc.•Prepared & submitted applications u/s 9(3) exports & 9(4) to Central Insecticide Board & Registration Committee (CIB&RC)

  • Tagros chemicals india (p) ltd
    • Chennai, Tamil Nadu, India
    • Regulatory Affairs Manager
      • Oct 2006 - Aug 2012
      • Chennai, Tamil Nadu, India

      •Registered technical & formulated pesticide products globally & India•Supported product registration under PT8 & PT18 under Biocide Products Directive (98/8/EC) and under Plant Protection Products Directive (91/414/EEC) in Europe•Prepared & filed applications for trademark (Brand name for Goods & Services) registration in India•Successfully got registration of products in Brazil, Mexico, Argentina, Australia & China and approval from WHOPES/FAO•Coordinated with CRO’s for timely generation 5-batch analysis, physio-chemical properties, toxicity & Eco-toxicity data as per (EC) No. 440/2008, US OPPTS & OECD•Prepared & submitted applications u/s 9(3) exports & 9(4) to Central Insecticide Board & Registration Committee (CIB&RC)•Coordinated field trials of Indoor Residual Spray (IRS), Insecticide Treated Nets (ITN) with Directorate General of Health Services, Malaria & Parasitic Disease Control Unit, Bangladesh

  • Bharat Rasayan Limited
    • New Delhi, Delhi, India
    • Technical Officer
      • Sep 2005 - Sep 2006
      • New Delhi, Delhi, India

      •Prepared applications for overseas registration of pesticides e.g. South America, Africa and Asia continent and replied for deficiency queries•Filed applications u/s 9(3) exports & 9(4) to Central Insecticide Board & Registration Committee (CIB&RC), India•Liaised with government and private CROs for testing of products for registration purpose•Internal Quality Auditor” for ISO 9001:2000

Education

  • Delhi University
    Master of Science in Agrochemicals & Pest Management
  • National Law School of India University
    Post Graduate Diploma in Intellectual Property Rights Law
  • All India Management Association (AIMA)
    Post Graduate Diploma in Management
  • Mahatma Phule Krishi Vidyapeeth, Rahuri
    Bachelor of Science in Agriculture

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