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Country Regulatory Manager/specialist

1 mese fa

Cesena, Italia UPL ltd A tempo pieno

**Country Regulatory Manager/Specialist (Cesena, Italy)**:

- Job Id: 5508- City: Cesena, Other/Not Applicable, Italy- Department: Regulatory- Function: Regulatory, Research and Development- Employee Type: Permanent Full Time- Seniority Level: Executive- Description:

- **About UPL**

**UPL is a leader in global food systems and with the acquisition of Arysta LifeScience, is now one of the top 5 agricultural solutions companies worldwide. With revenue of US$5 billion, UPL has presence in 130 countries. With market access to 90 percent of world’s food basket and focused on high-growth regions, UPL represents a compelling value proposition for growers, distributors, suppliers and innovation partners in a consolidating market. UPL offers an integrated portfolio of both patented and post-patent agricultural solutions for various arable and specialty crops, including biological, crop protection, seed treatment and post-harvest solutions covering the entire crop value chain.**

**Country Regulatory Affairs Manager/Specialist**

**Role purpose**

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

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.

**Accountabilities**
- Obtain, maintain and extend product authorisations in line with agreed business objectives (e.g. timelines) through
- Effective partnership with relevant teams (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 requirement for a defined portfolio of Plant Protection Products before evaluators/national authorities
- Carry out in full autonomy administrative tasks (eg. Formulation changes, implementation of new distributors and manufactures) and collateral activities (eg. PCN notification, communication with the customers, SDS management).
- Ensure compliant labelling, in accordance with regulatory authorisations and local packaging and labelling legislation.
- Manage documentation in internal and external archives and databases.
- ensure regulatory assistance and timely advice to sales force and other functions, being part of the local cross functional team.
- Maintain a strong knowledge of European and national legislation and monitor activities which could impact national existing or future authorisations of Plant Protection Products / Biostimulants.

**Knowledge, experience & capabilities**

Relevant knowledge
- Scientific background in one of the disciplines relevant for regulatory affairs
- Good understanding of regulatory processes in Italy and Europe
- Knowledge on one or more relevant EU Regulations (e.g. PPP 1107/2009, FP 1009/2019, REACH 1907/2006, CLP 1272/2008) and National Legislation (e.g. Decree PPP 55/2012, FP 75/2010)
- Knowledge on adjacent regulatory areas could be taken into consideration (e.g. detergents, cosmetics )

Relevant experience
- Regulatory experience in relevant registration procedures in Italy and Europe (2-5 years experience minimum)
- Experience with National fertiliser legislation (Decree 75/2010) and REACH will be a plus

Relevant technical, professional and personal competences
- Fluent in English and Italian
- Effective team worker
- Positive thinking and solution-orientation
- Effective time and task manger to ensure delivery of the business needs
- Ability to work under time pressure
- Ability to proactively manage complex interdisciplinary issues without being the expert in any one discipline
- Open to change and explore new way of working to overcome complexity.
- Good communicator
- Negotiation and advocacy skills are a plus
- Active management of the workload
- Willingness to try new approaches

**Critical success factors & key challenges**
- Detailed knowledge of relevant regional regulations and adjacent legislation
- Regulatory foresight to proactively manage arising issues
- Perseverance to ensure regulatory success
- Fluent in English in technical discussions
- Multidisciplinary and positive approach to propose solutions
- Willingness to try new approaches
- Positive thinking and solution-orientation

Location: Cesena, Italy

Contract: Full time, Permanent

**We are one team, for maximum impact. One team with shared goals. We all play for the team and no-one plays against team. We have a laser-like focus on what our customers need and want, on anticipating their future needs and how we can create innovative solutions and experiences for them.