Website UPL
UPL is a leader in global food systems. And with the acquisition of Arysta LifeScience, becomes one of the top 5 agricultural solutions companies worldwide. With revenue of approximately USD $5 billion, it has a footprint in 76 countries and sales in 130+ countries, with 10,800+ people worldwide…. read more Cropserve (Pty) Ltd. 74 Second Street Booysens Reserve Johannesburg 2091 South Africa
Role Summary
Manage routine activities, including but not limited to, studying and compiling scientific and legal documents to ensure that products allocated to the NPP portfolio are following governmental regulations. Work in partnership with the Project Lead: NPP on new project developments to ensure that all regulatory requirements are fully achieved to complement biological development in accordance with submission timelines and forecasted regulatory project budgets.
Role Responsibilities
Regulatory
Maintain the NPP portfolio under regulatory and legislative compliance within the geographic region under scope, i.e. South Africa (ZA). At times may be required to aid other portfolios; Fungicides, Insecticides, Fumigants, PGR’s, Fertilizers, Seed Treatments, Herbicides, IVM, Adjuvants and Export Countries.
Ensure registration of new products and maintain registrations of existing products within assigned portfolio/s within ZA.
Prepare, i.e. collect, evaluate (accuracy and integrity), organize, collate and maintain scientific, legal and regulatory information/data in a variety of formats, including but not limited to electronic databases and physical files, related to portfolio of products.
Ensure that the associated project regulatory expenses are paid on-time-in-full, in collaboration with R&D Administration Officer.
Report regularly (daily, weekly, monthly) on the status of products or projects and provide responses to questions/queries/correspondence to internal (management, other departments) and external stakeholders (headquarters, regulatory authorities) related to portfolio.
Work in Partnership and provide guidance to cross-functional teams such as Technical Product Development, Marketing and R&D PMO on regulatory requirements and the associated costs for submission of new business cases.
Liaise with Formulation Development for in-house product development and sample requirements for regulatory studies.
Ensure that suppliers of formulations and active ingredients meet the needs of ZA regulatory requirements.
Schedule and manage portfolio related product renewals on an annual basis.
Compile SDS’s for new products and maintain updates for existing products.
Keep up to date with changes in regulatory legislation and guidelines and inform relevant internal and external stakeholders.
Ensure that quality standards are met and submissions meet strict deadlines.
Support ad hoc requests relating to regulatory functions and related company initiatives.
Support other regulatory Portfolios/New Portfolio/New Product Category (hybrid products) based on company need; seasonal workload, and company financial necessity.
Promote teamwork, communication and foster a knowledge sharing culture.
Be actively involved in all regulatory EDER (Early Detection, Early Resolution), activities, e.g. (including but not limited to) sudden changes in legislation such as implementation of GHS, or CMR molecules phase-outs. Provide early warning to business on regulatory trends, decisions, and possible impact.
Responsible for the compilation of high-quality dossiers and/or submissions.
Create, modify and maintain operating procedures and processes pertaining to specific portfolio, with agreement of Sub-regional Regulatory Head.
Escalate all delays to sub-regional Regulatory Head and Regional Regulatory Head
Label management
Draft and maintain GHS compliant labels for new product registration submissions as well as for amendments to existing products.
Liaise with Supply chain Label Coordinator on printing of labels for new registered products.
Supply label briefs to the Label Coordinator and help proof read label artwork,
Provide supporting data for uploading and updating the global artwork management systems, eg. Karomi and local marketing platforms – UPL Website and Agri-Intel.
Document Courier
Responsible to courier documents to and from the ACT 36 offices and confirm receipt and collection of documents, as well to timeously communicate any feedback from ACT 36 to manager.
Contracts and Agreements
Ensure that all contracts and agreements are maintained for product portfolio registrations.
Any Other Job Related Details
Maintain physical and virtual files, trackers, Gannt charts, support with timeous information for monthly/quarterly/other frequency management/stakeholder update. Maintain confidentiality of all sensitive information.
Have an in-depth knowledge of relevant regulations and requirements for submission of registration applications
Knowledge, Skills and Experience Required
Technical Requirements:
Two to three years of experience in individual or team orientated projects in a science-based environment
Minimum of B.Sc but preferably a post-graduate qualification (Hons. or M.Sc) in Crop, Agriculture, Plant Pathology, Entomology, Microbiology, or Chemical sciences
Any experience in Project Management or team supervision would be an advantage but not a necessity.
Behavioural Requirements
Detail orientated and analytical is key to meet the high level of accuracy required for regulatory compliance. Working in a solution driven environment requires a self-motivated and persistent individual with a high level of creativity to work towards fact-based problem solving. Good sense of time-management and prioritization skills to support diverse projects running in parallel. Integrity and a professional approach to work.
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