Country Regulatory Manager

Rainbow Agro; Asti; In loco; EUR 40.000 - 65.000; Tempo pieno

Descrizione del lavoro

A leading agrochemical company seeks a Country Regulatory Manager in Italy. The role involves coordinating regulatory submissions and managing regional regulatory strategies for plant protection products. Candidates should have a higher education in agronomy and experience with regulatory authorities, particularly in accordance with EU regulations.

Competenze

• At least 3 years of experience as a country regulatory manager.
• Experience dealing with regulatory authorities.
• Experience with Regulation 1107/2009.

Mansioni

• Coordinate dossier preparation for regulatory submissions.
• Collaborate to implement regional regulatory strategies.
• Monitor changes in national legislation related to plant protection products.

Conoscenze

Knowledge of risk assessment

Self-motivation

Problem-solving skills

English proficiency

Formazione

Higher education in agronomy or related discipline

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, ranking among 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 that protect crops while caring for the environment. We aim to increase crop yields and foster mutual growth with our employees, partners, and farmers worldwide.

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., integrating its product system and marketing network based on our clear EU market strategy.

We are seeking an experienced expert to join us as a Country Regulatory Manager for plant protection products in Italy. If you want to be part of a dynamic international team, apply to be responsible for national authorizations and application submissions for registration of plant protection products.

Job Description and Tasks:

1. Coordinate dossier preparation and submission for plant protection products at the country level according to Regulation 1107/2009, in cooperation with the internal Regulatory Team or external consultants.
2. Collaborate with the Regulatory Team to develop and implement regional regulatory strategies, meet submission deadlines, and ensure timely product authorization and post-registration compliance.
3. Meet with regulatory authorities, CROs, laboratories, and organizations to support product registration and portfolio development.
4. Prepare prioritization lists of regional registration activities with key stakeholders and coordinate related regulatory activities 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. Work with local sales, distributors, and marketing teams.
8. Support the Efficacy Team in study contracting and Biodossier preparation.

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 trials management or Biodossier preparation.
• Experience in application preparation and submission processes.
• Proficiency in written and spoken English.
• Self-motivation and the ability to manage complex issues and prioritize workloads.

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