Monsanto Regulatory Affairs Manager in BRUSSELS, Belgium

The EME Regulatory Affairs Department is seeking a motivated Regulatory Affairs Manager based in Brussels .

This position provides overall regulatory support to the CP and seed applied solutions organization in EME by enabling, securing and maintaining product registrations, by providing strategic regulatory support regarding geographical and portfolio expansions and by monitoring and securing regulatory compliance at all time.

In this position you will:

  • Manage a team of regulatory specialists, provide guidance, coordinate the team’s workload

  • Build strong regulatory and technical internal expertise

  • Master the complexity of the Regulatory framework in the EME region and across countries in order to ensure tight coordination and consistent decision making across and within products.

  • Support CP & SAS regulatory organization with the coordination of regulatory dossiers (set-up coordination-review-submission-follow up)

  • Support the business from a regulatory perspective

Key Responsibilities:

Applications for authorisation (individual’s product portfolio):

  • Develop and implement regulatory strategies based on in-depth knowledge of applicable law

  • Manage team of regulatory specialists, coordinate team projects and team workload

  • Coordinate preparation of regulatory applications (science & cross-functional liaison)

  • Draft and review regulatory applications

  • Manage regulatory submissions from time of application to authorisation

Regulatory aspects linked to Commercial activities

  • Ensure regulatory compliance throughout life cycle (from launch until Support country launches

  • Support regulatory and commercial FTO

  • Support and implement product discontinuation strategies (as relevant)

Issue management

  • Support Corporate and Scientific Affairs in managing crises

External relations

  • Establish and maintain professional contacts with regulatory authorities in Europe

  • Use networks for intelligence gathering/influencing

  • Inter-company liaison/coordination

Staying current

  • Stay up-to-date with the latest developments in science, relevant legislation and guidelines

  • In depth understanding of the business and regulatory environment

Required Skills/Experience:

  • Leadership competences -experience in team management is an asset

  • Master degree or higher in relevant scientific discipline

  • Strong scientific background

  • Biology, agronomy, analytical chemistry

  • Adequate 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 Affairs Manager

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

Requisition ID: 01JGN

Job: Supply Chain/Logistics

Schedule: Full-time

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