Monsanto Regulatory Study/Trial and Compliance Manager - CP in BRUSSELS, Belgium

The EME Regulatory Affairs Department is seeking a motivated Regulatory study, trial and compliance Manager based in Brussels .

More specific key responsibilities for this role will be:

  • Regulatory field trial management (glyphosate & selectives): efficacy & residue trials

  • Link to TD & stewardship team to initiate trials

  • Trial protocol management (development -entry into ARM)

  • Contact to CRO’s – agreement management

  • Compliance management (EUP, audit where necessary, post-trial management)

  • Organize write up of field trial reports and BADs

  • Trial auditing (compliance)

  • Dossier support (glyphosate & Biologicals & selectives)

  • Coordinate product chemistry dossiers, phys-chem dossier sections & coordinate test item management

  • Coordinate Analytical methods sections

  • Coordinate residue section-MRL applications

  • Coordinate efficacy sections

  • Coordinate fate sections

  • Represent Monsanto in relevant external fora

  • ECPA environmental EG

  • ECPA efficacy WG

  • EPPO

  • RWG chair; fate & analytical TWG chair (pre- and post AIR)

  • Manage AIR conditions within Monsanto (product level) and within taskforce (a.i. level)

  • Master degree or higher in relevant scientific discipline

  • Strong agronomy background

  • Experience with field trial programs and regulatory efficacy dossiers for CP

  • Established experience in positioning and supporting product uses,

  • Strategic skills in optimizing time and resources by bridging/extrapolating between products or uses when relevant

  • Communication skills in order to provide clear guidance to consultants in charge of the trials and with business to share result analysis and regulatory expectations

  • Guidance on the communication of benefit of uses and products (close relationship with TD and marketing)

  • Adequat regulatory experience; profound understanding of European and country regulations (crop protection -biostimulants); in depth knowledge of dossier requirements. Experience with supporting regulatory in business teams are an asset

  • Team player

  • Excellent communicator (oral and written) in English; more languages are an asset

  • Excellent planner, organizer and initiative taker

  • Eager to learn

  • Engagement, commitment and perseverance are crucial qualities

Organization: GLB Regulatory Affairs51177232_

Title: Regulatory Study/Trial and Compliance Manager - CP

Location: Europe Middle-East-Belgium-Brussels-Brussels

Requisition ID: 01KBU

Job: Corporate Affairs

Schedule: Full-time

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