Regulatory Affairs Expert South East Europe BOLOGNA

Regulatory Affairs Expert South East Europe
Bologna
Emilia Romagna, BOLOGNA

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Regulatory Affairs Expert South East Europe Date:  Sep 18, 2024

Location:  Bologna, BO, IT



Rovensa is a global leader of sustainable solutions for agriculture with a great history and an ambitious dream: to feed the planet by helping farmers to produce healthy and nutritious food for all, all over the world. Safety, Empowerment, Ethics, Dedication and Striving are our SEEDS. It defines how we work every day, and the responsibility we all have towards our colleagues, our customers, our farmers, our business partners, and our planet. We are determined to keep our SEEDS growing. We need the right people on our team - those that love what they do and strive to contribute to Rovensa's mission. So, if you enjoy working in a fast-paced environment, plant our SEEDS with us and grow along the way, while cultivating a better future for the next generations.

You will be driving regulatory activities to ensure compliance and market access of Rovensa Next portfolio (biocontrol, bionutritional and biostimulant products) within countries of South-East Europe (Italy, Greece, Balkans, Romania, Bulgaria, etc. )

YOUR RESPONSIBILITIES: Obtain and maintain product authorizations (fertilizers, biostimulants, biocontrols) according to the portfolio strategy for Souty-East Europe. Drive the product registration plan & allocation of regulatory investment for your countries. Carry out regulatory activities for the Biocontrol portfolio such as data matching, dossier preparation, submission, evaluation monitoring and response to authorities, communicating progress and updating deadlines. Ensure that Rovensa Next product labelling, classification and sales comply with local regulations, provide relevant risk analysis in the region and initiate corrective measures when needed. Maintain Regulatory Affairs Information: product registrations, certificates of registration, approved labels and submitted dossier. Keep up-to-date knowledge of local regulations: national regulations on fertilizers, biostimulants, plant protection products, organic farming standards, other horizontal regulations and their trends. Be the main point of contact with country authorities in charge of product authorisation. Engage with stakeholders and industry associations to allow a workable regulatory framework. THE TALENT WE ARE LOOKING FOR: 2-3 years proven professional experience on product registration and regulatory assessmentGood knowledge of framework legislation and rules related to Regulation (EC) No 1107/2009Experience in plant protection products (PPP) and biocontrol, adjuvants, biosolution productsKnowledge in Regulation for Plan Protection norms (EU and national level)Very proficient in EnglishAbility to work independently and in a team environmentAnalytical person with strategic thinkingGood organizational skills to manage different countries at the same time handling complex topics WHAT WE OFFER:  Opportunity to work in a stimulating environment and in an international company. High level autonomy and responsibilityCompetitive salary and performance bonus

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