Regulatory Manager – (18014083)
Syngenta is a leading agriculture company helping to improve global food security by enabling millions of farmers to make better use of available resources. Through world class science and innovative crop solutions, our 28,000 people in over 90 countries are working to transform how crops are grown. We are committed to rescuing land from degradation, enhancing biodiversity and revitalizing rural communities.
• To obtain, maintain and extend product registrations in line with Syngenta’s business objectives.
• To plan workload following legal timelines, projects progress and business need.
• To contribute to the registration dossier preparation to ensure full completeness check and compliance with both EU and national requirements. For major dossiers, participation to ERPT when needed and when Portugal is zRMS.
• To provide inputs to finalize Part A and build up registration dossiers with all sections delivered by Submission Manager to ensure completeness check.
• To follow up evaluation process to respond to issues and national extra requirement, coordinating support from internal experts.
• To coordinate all the actions needed to prepare registration for PRM project with national crop teams and EAME Regulatory according to the gap agreed.
• To ensure regulatory compliance in Portugal: label, database, registration information (source AS, production site, packaging).
• To provide advice to the Business on trends/changes in the regulatory environment, which may affect the portfolio and key competitors.
• To support the Field Force needs on regulatory topics and information.
• To establish and maintain strong working relationship with Crop teams at national level and with the European Regulatory/Submission team as well as with Product Safety, providing and obtaining appropriate support.
• To build and maintain excellent working relations with evaluation experts.
• To act as function’s specialist on assigned secondary responsibilities (e.g. techno-regulatory focus role) and provide corresponding support to colleagues in the team.
Main relationship internals and externals
• European Regulatory Team: regulatory manager and submission manager.
• Country Unit/Country regulatory teams: regulatory manager and regulatory Country Head.
• Product Safety expert (JH).
• Product Biologist, Regulatory Biologist and Stewardship team.
• Portfolio team: CP Marketing and Technical Support.
• P&S: labelling, SDSs managers.
• Field Force.
• National authorities: mainly Ministry of Agriculture.
• Experts from Evaluation Institutes appointed by the Ministry of Health, Ministry of Agriculture and Ministry of Environment.
• Third party Companies for licensing in or out contact with regulatory team.
• Professional associations (Anipla).
• Academic and Scientific Community.
• Degree in Agronomic Science or equivalent in relevant scientific discipline and 5 year-experience in Regulatory Affairs of Plant Protection Products Companies.
• Sound scientific awareness and ability to assess technical data and provide guidance on product related issue management
• Good English level is a must, other languages knowledge is a plus
• Availability to travel not on a regulator basis
• Good problem anticipation and solving skills
• Critical information seeking and rational persuasion skills
• Excellent networking and influencing skills
• Strategic vision and ability to identify future regulatory threats and opportunities
• Effective team working and project management
• Performance orientation, delivering quality at the right speed
• IT advance skills.
Primary Location: Portugal
Job: Regulatory & Stewardship
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