Regulatory and Stewardship Specialist
Salary undisclosed
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236093W-01
Description
Description
- Regulatory and Stewardship Affairs
- Support the strategic planning and execution of Regulatory & Stewardship programs to realize Corteva business growth in Indonesia by managing registration of Crop Protection and/or Biotech products as aligned with country & global teams.
- Develop regulatory dossiers in collaboration with the regional and global registration teams for the timely registration of crop protection and biotech products in line with business objectives.
- Execute the registration applications and approvals of crop protection and/or biotech products for import and cultivation to the relevant government organization
- Build a transparent, consistent, bold, and countable communication on the regulatory information, impact on the business and implications
- Able to seek innovative approaches to address new and existing challenges, evaluate options and facilitate improving work process and output.
- Stakeholder Engagement and Outreach
- Build and strengthen relationships with key stakeholders in government, academe, community and industry for acceptance of Corteva products.
- Regulatory Science and Operations
- Plan and execute the local requirement studies to support the registration and commercialization of crop protection and biotech products.
- Work closely with Integrated Field Science team and other relevant functions to ensure that registration trial programs are appropriately resourced.
- Lead the development of technical trial reports and ensure requirements by relevant government regulatory agencies are met.
- Regulatory Compliance and Product Stewardship
- Review the commercial labels for regulatory compliance.
- Manage and oversee processes to ensure compliance with all government regulations, permit conditions and internal processes and standards throughout the product life cycle.
- Take part in the relevant product stewardship program led by the Product Stewardship team.
- Coordinate with the Supply Chain and Customer Service team to ensure the regulatory compliance for import and export.
- Bachelor's or master's Degree (favorable) in Biotechnology, Crop Protection, Agriculture, Chemistry, Toxicology, or related courses
- Preferably with 5-6 years of experience in regulatory or related technical disciplines and with good understanding of regulatory framework and processes for crop protection agricultural or biotech products. Familiarity with regulatory dossier preparation.
- Ability to interpret regulatory requirements, analyze range of studies and extract relevant information for drafting of comprehensive dossiers for submission
- Fast learning abilities, cross-functional and cross-cultural working adaptation.
- Good organizational and project management skills and ability to work to deadlines
- Regular travel to regulatory agencies
- Good communication skill
- Good scientific and technical report writing skills.
- Computer proficient (word processing, spreadsheets)
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