Country Regulatory Affairs Italy

5 giorni fa

Cesena, Italia Upl-Ltd A tempo pieno

UPL Limited (NSE: UPL & BSE: 512070, LSE: UPLL) is a global provider of sustainable agriculture products and solutions, with annual revenue exceeding $6bn.
We are a purpose-led company.
Through OpenAg, UPL is focused on accelerating progress for the food system.
We are building a network that is reimagining sustainability, redefining the way an entire industry thinks and works – open to fresh ideas, innovation, and new answers as we strive towards our mission to make every single food product more sustainable.
Job Purpose: The resource will be responsible for all the regulatory activities related to the assigned products, reporting to the Country Regulatory Lead and working with a high level of autonomy.
Accountable on regulatory affairs of Plant Protection Products and/or Biostimulants in Italy and Malta to meet the expected objectives in line with agreed business strategies.
Job Location: Cesena, Italy Job Description: Obtain, maintain and extend product authorizations in line with agreed business objectives (e.g.
timelines) through Effective partnership with relevant teams (R&D, Sales and Marketing) to represent regulatory and safety positions and facilitate business decisions.
Effective management of relations and communication with Member State regulatory authorities and internal EU Regulatory team.
Follow-up evaluation processes to respond to issues and national extra requirements for a defined portfolio of Plant Protection Products before evaluators/national authorities.
Collaborate with regional colleagues on dossier preparation/revision ensuring that local requirements and risk assessments are considered and correctly performed.
Submission of applications and defense papers.
Ensure regulatory assistance and timely advice to the sales force and other functions, being part of the local cross-functional team.
Carry out in full autonomy administrative tasks (e.g.
formulation changes, implementation of new distributors and manufacturers) and collateral activities (e.g.
PCN notification, communication with the customers, SDS management) at the National level.
Ensure compliant labeling, in accordance with regulatory authorizations and local packaging and labeling legislation.
Manage documentation in internal and external archives and databases.
Maintain a strong knowledge of European and national legislation and monitor activities which could impact national existing or future authorizations of Plant Protection Products and/or Biostimulants (possible involvement in biocide).
Qualifications and Skills: 2 to 6 years Regulatory experience in relevant registration procedures in Italy and Europe.
Scientific background in one of the disciplines relevant for regulatory affairs.
Knowledge on one or more relevant EU Agrochemical Regulations (PPP 1107/2009, FPR 1009/2019).
Experience with National legislation (PPP DPR 55/2012, Fertilizer DLgs 75/2010) will be a plus.
Experience with biocide regulation (BP 528/2012), REACH and CLP will be a plus.
Dossier writing, risk assessment conduction and study monitoring are a plus.
Fluent in English and Italian.
Preferred Qualifications and Skills: Positive thinking and solution-orientation.
Willingness to try new approaches.
Effective time and task management to ensure delivery of the business needs.
Ability to proactively manage complex interdisciplinary issues without being the expert in any one discipline.
Active management of the workload and related timeline.
Open to change and explore new ways of working to overcome complexity.
Good communicator and effective team worker.
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