Syngenta Crop Protection
- European Regulatory Manager
Role Purpose: To achieve and maintain the best European registrations for designated AI’s within a given portfolio.
Role Accountabilities (& outputs):
Contribute regional regulatory view to development of global regulatory strategy (regional regulatory knowledge and foresight)
Provide regional regulatory leadership and tactics for a portfolio of regional AI‘s in line with global regulatory strategy (EU submissions, registration plans, key EU position documents, issue management, strong input to regional pillar and project teams)
Provide regional support to countries in gaining, maintaining and extending registrations for portfolio of ai‘s. (country specific annex III dossiers, technical positions, submission coordination, issue management)
Provide regional regulatory leadership in identified topic areas, e.g. MRLs (tactics, expert advice, position statements, influencing plan)
Arysta LifeScience SAS
- Responsable Homologation Sud Europe - Chef projet
Regulatory Affairs Manager Southern Europe
- Preparation and follow up of registration dossiers (for new registration, extension of uses, renewal, transfer....) in Spain, Portugal, Italy, Greece and other Balkans countries: Croatia, Serbia, Macedonia, Albania...
including meeting with the authorities
- Meeting/coordination with the commercial, marketing and development teams about the new registration possibilities and strategies in those countries.
- Preparation and/or adaptation from a core dossier, of annex II and annex III dossiers including redaction of these annexes and monitoring of all the required studies for each section 5 batch analysis, physico-chemical, analytical method, toxicology; residues studies and ecotoxicology for national registration dossiers.
- Follow up of national legislation
- Contact/ meeting with local consultants
- Meeting with the local commercial team, distributors
European Regulatory Manager
- Accountable for the development and implementation of the regulatory strategy, positioning and core dossier, for a group of AIs
- Liaises regularly with colleagues in other BU’s and key countries through Registration Project Team (RPT) Meetings and to provide a globally consistent view on project content, issues and regulatory strategy
- Defines, agrees and implements ( after business agreement) work packages and studies together with input from expert external consultants
- Provides inputs to the global regulatory studies database and ensures appropriate documentation is available for use as required.
- Maintains the IRM – registration status
- Maintains a registration development plan ( new registrations, re-registrations and study plan to support these) within the BU
- May be the global expert for an AI