Regulatory Specialist: Herbicides - Pretoria

Role Responsibilities

Regulatory Compliance

• Maintain the Herbicide, IVM, Adjuvant, Fumigant and Rodenticide portfolios under regulatory and legislative compliance within the geographic region under scope, i.e., South Africa (ZA).
• 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 needs, 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.
• Provide supporting data for uploading and updating the global artwork management systems, e.g., Karomi and local marketing platforms - company Website and Agri-Intel.

AGRI-INTEL

• Responsible as single point of contact with Agri-intel. To ensure latest updated product label information is submitted timeously to Agri-intel.

Contracts and Agreements

• Ensure that all contracts and agreements are maintained for product portfolio registrations

General

• 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.

Knowledge, Skills And Experience Required

• 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, Microbiology or Chemical sciences
• Any experience in Project Management or team supervision would be an advantage but not a necessity.
• 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.