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| Division |
Crop Protection |
| City |
Greensboro |
| State/Province |
North Carolina [NC] |
| Function |
Research & Product Development |
| Position Title |
Regulatory Specialist I, II or III |
| Job ID |
1848 |
| Role Purpose/Accountabilities |
This role works independently within general guidelines to provide technical input and oversight for a wide variety of compliance-related activities in the Compliance and Regulatory Support group of the Regulatory Affairs Department.
• Coordinates activities for provision of US regulatory documents to Syngenta locations world-wide to support international product registrations
• Coordinates, reviews and submits the annual Pesticide Production Reports for all Syngenta-owned domestic and foreign pesticide-producing establishments for compliance with FIFRA Section 7 requirements.
• Provides administrative support for Syngenta’s adverse effects committee. Coordinates collection and reporting of product incident information from the Syngenta Customer Center and contracted poison control center, Prosar. Prepares and submits monthly, quarterly and annual adverse effects summaries and reports to EPA and assists in training staff on FIFRA 6a2 and TSCA 8e requirements.
Accountabilities
• International Registration Support:
o Identify country-specific documents required to support international registrations of Syngenta products
o Work with Regulatory Managers, Product Quality Control, Product Chemistry, Contract Manufacturing, Supply Chain and EPA to assemble required documents for international registration submissions.
• FIFRA Section 7 Pesticide Production Reporting
o Coordinate the completion of annual production reports from all Syngenta-owned domestic and foreign pesticide producing establishments.
o Submit EPA-required production reports by agency due date.
• FIFRA and TSCA Adverse Effects Reporting
o Serve as key contact and coordinator for all adverse effects reporting for Syngenta products
o Collect and information from PROSAR and Customer Center concerning incidents with Syngenta products and report to EPA per FIFRA 6a2 reporting requirements
o Manage the Syngenta’s reporting requirements for adverse effects per FIFRA 6a2 and TSCA 8e; work with Global and US PRF committees to collect, review and report information per EPA requirements and time tables.
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| Knowledge, Skills & Experience |
Critical knowledge
• Associates degree or equivalent
• Proficient in use of MS Office products including Word, Excel, Power Point and Access
• Experience using Documentum-based document management systems
• Knowledgeable about regulatory terminology and EPA guidelines
• Some knowledge of agriculture and pesticide industry is desirable
Critical experience
• 2 years previous experience in a regulatory, product development or other technical area
• 1 year experience coordinating interactions between colleagues at domestic and international locations
Critical technical, professional and personal capabilities
• Candidate should have strong skills in: communication, interpersonal relations, organizational knowledge, planning and organization, standard office software and problem solving.
Critical leadership capabilities
• Drives results – coordinates activities across the organization to meet EPA requirements and deadlines for compliance
• Set Direction – provide guidance to stakeholders across the company concerning reporting requirements and gain commitment to meet critical reporting deadlines
• Create Edge – provide effective follow-up mechanisms to ensure all stakeholders in compliance processes provide required feedback in a timely manner
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| Critical Success Factors & Key Challenges |
• Must be highly organized & pay attention to detail.
• Performance Orientation: Makes things happen – delivering quality at speed
• Customer Orientation: Knowledge and insights about customers and needs; customer first in work and interpersonal dealings.
• Change Orientation: positive attitude to change and progress; successfully implements change programs.
• Leadership: Gives / seeks feedback systematically & constructively.
• Organization Effectiveness: Develops networks across the organization; seeks / shares best practice, develops synergies.
• Strategic Ability: thinks outside the box – finds novel solutions.
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| Additional Information |
• Two years current position preferred. Candidates who have been in their current position a minimum of one year will be considered if they have the approval of their current business unit leader and hiring business unit leader.
• All applicants must be eligible to work in the U.S.
• Travel requirements – minimal
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