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Regional Regulatory Manager - Biosolutions

Job Id:  2055
City: 

Nogueres, Pyrenees-Atlantiques, France

Department:  R&D Regulatory - Registrations
Function:  Regulatory, Research and Development
Employee Type:  Permanent Full Time
Seniority Level:  Mid-Senior level
Description: 

About UPL

UPL is a leader in global food systems and with the acquisition of Arysta LifeScience, is now one of the top 5 agricultural solutions companies worldwide. With revenue of US$5 billion, UPL has presence in 130 countries. With market access to 90 percent of world’s food basket and focused on high-growth regions, UPL represents a compelling value proposition for growers, distributors, suppliers and innovation partners in a consolidating market. UPL offers an integrated portfolio of both patented and post-patent agricultural solutions for various arable and specialty crops, ncluding biological, crop protection, seed treatment and post-harvest solutions covering the entire crop value chain.

 

Role purpose

 

Regulatory leadership of assigned active substances and/or products to ensure delivery of the portfolio objectives in line with agreed business strategies and budget

Accountabilities

 

  • Obtain and maintain EU approval of active substances in line with agreed portfolio objectives through
    • Effective management of relations and communication with Rapporteur Member States, DG SANCO, EFSA and internal EU Regulatory team
    • Effective partnership with relevant teams (Sales and Marketing) to facilitate business decisions and represent regulatory and safety positions
    • Effective coordination of work programmes with consultants and contract research organisation. Responsible for placing and monitoring the relevant studies in external laboratories. Responsible for project budget.
    • Ensure regulatory databases are used effectively and updated regularly
  • Obtain and maintain EU Member State product authorisations for biostimulants and biosolutions in line with agreed business objectives through
    • Effective partnership with relevant teams (Sales and Marketing) to represent regulatory and safety positions and facilitate business decisions.
    • Effective management of relations and communication with Member State regulatory authorities and internal EU Regulatory team.
    • Effective coordination of work programmes with consultants and contract research organisation. Responsible for placing and monitoring the relevant studies in external laboratories. Responsible for project budget.
    • Ensure regulatory databases are used effectively and updated regularly
  • Provide support to non EU countries (CIS, North African Countries, Turkey)
  • For assigned non-AS responsibilities (focus roles)
    • Source of expertise within EU regulatory for any assigned focus role and share current understanding and potential developments to the wider regulatory community
    • Provide high quality inputs to IBMA/EBIC/Crop Life Europe teams (if applicable) in line with agreed UPL objectives
  • Coaching of up to one assigned regulatory manager as appropriate
  • Provide regulatory insights into competitor portfolios to key stakeholders

 

 

 

Knowledge, experience & capabilities

 

 

Critical knowledge

  • Scientific background in one of the disciplines relevant for regulatory
  • Good understanding of regulatory processes in the EU

 

Critical experience

  • Regulatory experience in the EU (at least 8 years)
  • Negotiation and advocacy skills

 

Critical technical, professional and personal capabilities

 

  • Effective time and task management to ensure delivery of the business needs
  • Delivery of quality work even under time pressure
  • Ability to manage complex issues without being the expert in any one discipline
  • Effective team worker
  • Openness and willingness to challenge the accepted ways of working and to implement new ones
  • Good communicator

 

Critical leadership capabilities

 

  • Active management of the workload
  • Willingness to try new approaches

 

Critical success factors & key challenges

 

  • Detailed knowledge of relevant regional regulations and adjacent legislation
  • Regulatory foresight to proactively manage arising issues
  • Perseverance to ensure regulatory success
  • Fluent in English in technical discussions and advocacy

We are all about connecting with people, in a human way – showing respect, demonstrating trust, celebrating diversity. For us technology is an enabler, not the endgame. We see the value in human connectivity and how it creates new opportunities for everyone. With this, comes our promise to protect people’s safety in every way we can.