Regulatory Specialist

3 weeks ago

Durban, South Africa Mayfly Agri (Pty) Ltd Full time

**Minimum requirements for the role**:

- Must have a B.Sc. but preferably a post-graduate qualification (Hons. or M.Sc.) in Crop, Microbiology or Chemical sciences
- Minimum 4 years experience in individual or team orientated projects in a science-based environment is essential
- Detail orientated and analytical skills is key to meet the high level of accuracy required for regulatory compliance
- Must be self-motivated and persistent with a high level of creativity to work towards fact-based problem solving.
- Integrity and a professional approach to work is important
- Must have a good sense of time-management and prioritization skills to support diverse projects running in parallel
- Liaising Ensuring Regulatory Compliance by maintaining the Herbicide, IVM, Adjuvant, Fumigant and Rodenticide portfolios under regulatory and legislative compliance within the geographic region under scope, i.e., South Africa (ZA).
- Ensuring registration of new products and maintaining registrations of existing products within assigned portfolio/s within ZA.
- Collecting, evaluating, organizing, collating and maintaining 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.
- Ensuring that the associated project regulatory expenses are paid on-time-in-full, in collaboration with R&D Administration Officer.
- Reporting regularly (daily, weekly, monthly) on the status of products or projects and providing responses to questions/queries/correspondence to internal and external stakeholders.
- Working 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.
- Liaising with Formulation Development for in-house product development and sample requirements for regulatory studies.
- Ensuring that suppliers of formulations and active ingredients meet the needs of ZA regulatory requirements.
- Scheduling and managing portfolio related product renewals on an annual basis.
- Compiling SDS's for new products and maintain updates for existing products.
- Keeping up to date with changes in regulatory legislation and guidelines and informing relevant internal and external stakeholders.
- Ensuring that quality standards are met, and submissions meet strict deadlines.
- Supporting ad hoc requests relating to regulatory functions and related company initiatives.
- Supporting other regulatory Portfolios/New Portfolio/New Product Category (hybrid products) based on company needs, seasonal workload, and company financial necessity.
- Promoting, communicating and fostering a knowledge sharing culture.
- Being 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.
- Compiling high-quality dossiers and/or submissions.
- Managing labels by drafting and maintaining GHS compliant labels for new product registration submissions as well as for amendments to existing products.
- Liaising with the Supply Chain Label Coordinator on printing of labels for new registered products.
- Providing data for uploading and updating the global artwork management systems, e.g., Karomi and local marketing platforms.
- Responsible as single point of contact for the company with Agri-intel to ensure latest updated product label information is submitted timeously to Agri-intel.
- Ensuring that all contracts and agreements are maintained for product portfolio registrations.

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