**Country Regulatory Affairs Italy & Malta**:
- Job Id: 10280
- City: Cesena, Emilia Romagna, Italy
- Department: R&D Regulatory - Registrations
- Function: Regulatory Science & Government Affairs
- Employee Type: Permanent Full Time
- Seniority Level: Not Applicable
- Description:
**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
- 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 requirement 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.
- Ensure regulatory assistance and timely advice to 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 manufactures) and collateral activities (e.g.
PCN notification, communication with the customers, SDS management) at National level.
- Ensure compliant labelling, in accordance with regulatory authorizations and local packaging and labelling 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 authorisations 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 manage 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 way of working to overcome complexity.
- Good communicator and effective team worker.
**We are one team, for maximum impact.
One team with shared goals.
We all play for the team and no one plays against the team.
We have a laser-like focus on what our customers need and want, on anticipating their future needs and on how we can create innovative solutions and experiences for them.
**
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