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Regional Regulatory Manager - Insecticides

Job Id:  1509
City: 

EVESHAM, Richmond upon Thames, United Kingdom

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, including biological, crop protection, seed treatment and post-harvest solutions covering the entire crop value chain.

Main mission

 

Successful approval of active ingredients (AI’s) and formulated products in full compliance with regulations and within budget.

 

Scope

 

Dimension (area, key words, key figures): EU28 and CIS

Objectives of the job:

  1. Plan/manage all regulatory development/needs (including required data generation), linked to assigned molecules in order to complete dossier preparation on time and secure registrations.
  2. Write European product registration dossiers (except the Biological Assessment Dossier) in order to allow the country registration managers (CRM) to make timely submissions in their respective countries.
  3. Offer CRLs scientific support to answer regulatory questions on assigned molecules.
  4. Regulatory intelligence on a specific scientific topic as assigned. Participate in conferences or workshops and maintain a high level of awareness of developments of the science (Guidance documents, risk assessment approaches, methodologies and models, where relevant) related to that topic and share the knowledge with appropriate colleagues.

 

Position in the organization chart

Report to: Regulatory Team Lead – Insecticides/Acaricides & Biosolutions

In relation with: services (production, finance, etc.) 

In contact with R&D, marketing, commercial, technical, supply chain, formulations, scientific regulatory support group, product performance, regulatory compliance and stewardship, finance, IT in AWE, Global R&D functions, R&D in other BU

 

Job expectations

 

  • RESPONSIBILITIES

Build a strong regulatory team network in countries from the B.U. Europe where UPL has regulatory personnel.

Responsible for ensuring that regulatory submissions and registrations are on time and within agreed budgets.

Ensure regulatory databases are used effectively and updated regularly.

Work with the technical development manager, product performance manager and marketing managers to create plans for new product strategies and registrations.

Ensure that all registrations are compliant with the legislation in place.

Be aware of the evolving regulatory environment with respect to new guidance and regulations.

In addition, take accountability for molecules with the responsibilities of a regulatory manager as outlined below.

Be the regulatory expert for specific plant protection products. This means understanding the chemical specification, the toxicological and environmental safety profile for assigned AI’s and formulated products, how they are used and the key issues that need to be managed.

Develop and maintain a registration programme for each AI within the portfolio of assigned products which covers maintenance, re-registration, new uses of existing products and new formulations to improve performance or for differentiation.

Establish effective contacts with regulatory authorities and ensure that they understand Arysta plans and objectives, especially for AI’s that may not yet be registered in their country.

Represent the company’s interests (defense of product safety, advocacy, resolution of issues preventing registration, regulatory developments, etc.) at meetings with regulatory authorities and at other international meetings of regulators and industry.

Establish an external reputation for regulatory excellence.

Be the primary contact point with our country organizations and distributors as the Arysta European regulatory expert for assigned molecules and related products.

Understand the country perspective and develop jointly agreed plans and priorities and ensure these are reflected in the AI programs.

Maintain a record of the registration status for the AI’s and formulated products in the assigned portfolio.

Liaise with marketing managers, technical development managers and CRLs to ensure that renewal of specific registrations is justifiable from commercial and technical standpoints, to ensure the most cost-effective and efficient use of available regulatory resource.

 

Provide expert advice to marketing and sales.  Be a key member of the product family team, led by the Marketing Manager.

Maintain an awareness of the regulatory status of competitor products –prepare and regularly update a SWOT analysis and provide advice to the product family so that Arysta products can be positioned optimally in the context of the revised EU Directive.

Establish clear relationships with contractors and build strategic partnerships with them and other external collaborators, making optimal use of external resources so that sufficient time can be given to the more strategic elements of the job.

Manage the budget for agreed programs within the assigned portfolio.

 

 

  • EXPECTED CONTRIBUTIONS

Prepare a regulatory strategy document for each assigned AI, which covers the main points outlined in the accountabilities.

Prepare a summary of plans and priorities for each assigned AI together with Critical Success Factors (CSFs). Communicate these plans to the R&D team and to marketing and sales colleagues.

Agreed registration plan to be delivered on time and to specification and within budget.

Be pro-active, take initiative, be critical, show diligence and patience, be precise (good compromise between quality and time needed to write the dossier), work in a more or less autonomous way, in a well-structured, well organized manner to write clear technical dossiers with sound argumentations.

 

Key competencies required for the role

 

  • Highly developed advocacy and negotiating skills.
  • Proven track record of dealing with regulatory authorities.
  • Excellent verbal and written communication skills to interact with key external and internal stakeholders as described above.
  • Sound knowledge of varied scientific disciplines.
  • Expert in understanding and interpreting complex scientific data.
  • Proven ability to meet critical dossier submission deadlines and manage multiple business-critical projects.
  • Proven experience of managing a portfolio of an active ingredient.
  • Advanced computer literacy for the use of Excel, databases and other software is essential.

 

Functional competences:

 

Business Competencies

  • Must be able to work collaboratively in multidisciplinary project teams with other scientists, global and regional regulatory managers and other colleagues to ensure the business goals for the products are met

Technical Competencies

  • Excellent problem solving skills and ability to think logically and systematically
  • Demonstrated knowledge of EU pesticide regulatory requirements

Personal Competencies

 

  • Possess initiative and motivation to work with a minimum of guidance
  • Have excellent organizational skills and be able to prioritize projects appropriately
  • Be able to work well under pressure while maintaining a positive attitude

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.