Regulatory Affairs Manager (w / m / d)

Rainbow Agro; Venezia; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading crop protection global company is looking for a Country Regulatory Manager based in Italy. This role involves managing the registration processes for plant protection products, ensuring compliance with European regulations. The successful candidate will liaise with authorities and coordinate regulatory activities, contributing to significant product authorization efforts.

Competenze

• Minimum 3 years of experience in agrochemical regulatory management.
• Experience with regulatory authorities and submission processes.
• Familiarity with EU Regulation 1107/2009.

Mansioni

• Coordinate dossier preparation for plant protection products.
• Develop regional regulatory strategies and ensure compliance.
• Engage with regulatory authorities and manage budget projects.

Conoscenze

Regulatory knowledge

Risk assessment

Collaboration

Project management

Proficiency in English

Descrizione del lavoro

We are a leading crop protection company that produces, distributes, and markets 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. We aim to improve agricultural productivity by increasing crop yields and working collaboratively with our employees, partners, and farmers worldwide for mutual growth.

The EU market is considered 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. Following this acquisition, Rainbow is rapidly integrating its product system and marketing network based on its clear strategic plan for the EU market.

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 the registration of plant protection products.

Your responsibilities will include:

1. Coordination of dossier preparation and submission for plant protection products at the country level in accordance with Regulation 1107/2009, in cooperation with the internal Regulatory Team or external consultants.
2. Collaborating with the Regulatory Team to develop and implement regional regulatory strategies to meet submission deadlines and ensure timely product authorization and post-registration compliance.
3. Engaging with regulatory authorities, CROs, laboratories, and organizations to support product registration and portfolio development.
4. Preparing prioritization lists of regional registration activities in collaboration with key stakeholders and coordinating related regulatory activities for the assigned portfolio.
5. Managing the approved budget for projects.

Qualifications:

• 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.
• Proficiency in written and spoken English.