Dossier and Application Coordinator

4 weeks ago

Régina SK, Canada Rainbow Agro Full time

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 dossier and application coordinator for plant protection products. Apply if you want to join a dynamic international team as expert responsible for study verification and dossier preparation for registration of plant protection products in European Union.

We have office in Spain and will set up office in Poland, work at office or remote are both acceptable.

Job description and tasks: 

Coordination of dossier preparation for plant protection products in EU in cooperation with internal Expert Team or external consultants.

Manage the dossiers in coordination with the EU Regulatory Head, Headquarters, the consultants, and the Contract Research Organizations (if any) to ensure timely submissions and the approval/authorization are gained on time.

Monitor and follow up registrations progress in coordination with the local representatives or consultants, fill the registration and project management data bases and reports.

Cooperation with Country Registration Authorities responsible for authorisation of plant protection products. Evaluating Authority requests and comments based on knowledge, legislation and expert opinions.

Propose and then manage the approved budget for projects in coordination with the internal Expert Team, EU Regulatory Head and Headquarters.

Checking data protection status and providing advice to registration strategy.

Monitor changes in EU legislation related to active substances and plant protection products.

Requirements: 

Higher education: agronomy, chemistry, biology or equivalent discipline.

At least 3 years’ experience as active substance or dossier coordinator in an agrochemical company.

Solid experience within Risk Assessment, regulatory professional in the area of plant with experience of Regulation 1107/2009, Annex III dossierand Annex II renewals.

Experience in preparation of draft registration reports for plant protection products in sections: B1, B2&B4 or B5, or B6, or B7, or B8 or B9 will be advantageous.

Very good level of written and spoken English, other language skills are advantageous.

Self-motivation.

Ability to manage complex issues and prioritize workload.

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