Country Regulatory Manager

JR Italy; Vicenza; In loco; EUR 45.000 - 75.000; Tempo pieno

Descrizione del lavoro

A global leader in crop protection, JR Italy is seeking an experienced country regulatory manager to handle national authorizations and application submissions for plant protection products. The role involves coordinating regulatory submissions, managing budgets, and collaborating with various teams to ensure compliance with regulations.

Competenze

• At least 3 years’ experience as a country regulatory manager or expert.
• Experience dealing with regulatory authorities.
• Very good level of written and spoken English.

Mansioni

• Coordination of dossier preparation and submission for plant protection products.
• Work with local sales/distributor and marketing team.
• Monitor changes in national legislation related to plant protection products.

Conoscenze

Regulatory compliance

Risk assessment

Project management

Self-motivation

Formazione

Higher education in agronomy or equivalent discipline

Descrizione del lavoro

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Rainbow Agro is a global leading crop protection company, was founded in Jinan, China, in 2005 by a group of entrepreneurs. We are a leading crop protection company that produces, distributes and markets crop protection products and now it is one of the world’s top eleven agrochemical companies. Our focus is on the crop protection market, and our commitment is to be a First Class Global leader in this segment. Rainbow, all about growing.

We take improving agricultural productivity as our duty. With efficient and sustainable solutions, we carefully protect crops while caring for the environment. We strive to increase crop harvest yields, and work together with our employees, partners and farmers from all over the world, aiming mutual growth where everyone wins.

EU market is believed to be one of Rainbow’s major markets in its strategic plan. Since November 2022, Rainbow announced the acquisition of 100% stake in Spanish Agrochemical Company Exclusivas Sarabia S.A. in cash. Since the acquisition of Exclusivas Sarabia, Rainbow is rapidly integrating its product system and marketing network, based on its clear strategic plan for the EU market.

We are looking for an experience expert as country regulatory manager for plant protection products in Italy. Apply if you want to join a dynamic international team as country regulatory manager responsible for national authorisations and application submission for registration of plant protection products.

Job description and tasks:

• Coordination of dossier preparation and submission for plant protection products on country level according to Regulation 1107/2009 in cooperation with internal Regulatory Team or external consultants.
• Cooperation with Regulatory Team to develop and implement the regional regulatory strategy, to meet submission deadlines and ensure timely product authorization and post registration requirements.
• Meeting with regulatory authority, CRO, laboratories, organizations to support product registration and portfolio development.
• Preparation prioritization lists of regional registration activities in collaboration with key stakeholders and coordination the related regulatory activities for assigned portfolio.
• Managing the approved budget for projects.
• Monitor changes in national legislation related to active substances and plant protection products.
• Work with the local sales/distributor and marketing team.
• Supporting Efficacy Team in study contractation and Biodossier preparation.

Requirements:

• Higher education: agronomy or equivalent discipline.
• At least 3 years’ experience as country regulatory manager or expert for plant protection products in an agrochemical company.
• Experience dealing with regulatory authorities.
• Knowledge about risk assessment and experience with Regulation 1107/2209.
• Experience in efficacy trials management or Biodossier preparation.
• Experience in preparation and submission process of applications.
• Very good level of written and spoken English.
• Self-motivation.
• Ability to manage complex issues and prioritize workload.