Country Regulatory Manager

Rainbow Agro; Udine; In loco; EUR 40.000 - 70.000; Tempo pieno

Descrizione del lavoro

A global leader in crop protection, Rainbow Agro seeks a Country Regulatory Manager in Italy. This role involves overseeing national authorizations for plant protection products, coordinating regulatory submissions, and ensuring compliance with EU regulations. Ideal candidates will have a background in agronomy, strong regulatory expertise, and proficient English skills.

Competenze

• At least 3 years of experience as a country regulatory manager in agrochemicals.
• Experience dealing with regulatory authorities.
• Proficiency in English (written and spoken).

Mansioni

• Coordinate dossier preparation and submission for plant protection products.
• Develop regional regulatory strategies and ensure timely product authorization.
• Engage with regulatory authorities and support product registration.

Conoscenze

Regulatory knowledge

Risk assessment

Project management

Communication

Formazione

Higher education in agronomy

Descrizione del lavoro

Rainbow Agro is a global leading crop protection company, founded in Jinan, China, in 2005 by a group of entrepreneurs. We produce, distribute, and market crop protection products, making us 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 is all about growing.

We prioritize improving agricultural productivity through efficient and sustainable solutions, carefully protecting crops while caring for the environment. We aim to increase crop yields and work collaboratively with our employees, partners, and farmers worldwide for mutual growth.

The EU market is a major focus in Rainbow’s strategic plan. Since November 2022, Rainbow acquired 100% stake in Spanish agrochemical company Exclusivas Sarabia S.A., and is rapidly integrating its product system and marketing network based on its strategic EU market plan.

We are seeking an experienced expert for the role of Country Regulatory Manager for plant protection products in Italy. Join our dynamic international team to oversee national authorizations and manage application submissions for plant protection product registration.

Job Description and Tasks:

1. Coordinate dossier preparation and submission for plant protection products at the country level according to Regulation 1107/2009, collaborating with internal Regulatory Teams or external consultants.
2. Work with the Regulatory Team to develop and implement regional regulatory strategies, meet submission deadlines, and ensure timely product authorization and post-registration compliance.
3. Engage with regulatory authorities, CROs, laboratories, and organizations to support product registration and portfolio development.
4. Create prioritization lists of regional registration activities with key stakeholders and coordinate related regulatory tasks for the assigned portfolio.
5. Manage the approved budget for projects.
6. Monitor changes in national legislation related to active substances and plant protection products.
7. Collaborate with local sales, distributors, and marketing teams.
8. Support efficacy studies by contracting studies and preparing Biodossiers.

Requirements:

• Higher education in agronomy or a related discipline.
• At least 3 years of experience as a country regulatory manager or expert for plant protection products in an agrochemical company.
• Experience dealing with regulatory authorities.
• Knowledge of risk assessment and experience with Regulation 1107/2009.
• Experience in efficacy trial management or Biodossier preparation.
• Experience in the application submission process.
• Proficiency in written and spoken English.
• Self-motivated with the ability to manage complex issues and prioritize workload.

Please send your CV to the contacts below: Irena, Bogusław, Elisa.