Regulatory Specialist

SUMMARY:

An importer, exporter and distributor of agricultural and pharmaceutical chemicals is seeking an experienced Regulatory Specialist to support the regulatory activities / requirements of the company according to guidelines published by relevant regulatory authorities for SADC and Australasia.

POSITION INFO:

Minimum requirements for the role:

• Must have tertiary qualification in Pharmacology, Zoology, Entomology, Horticulture or similar
• Previous regulatory experience, ideally in crop protection, environmental science or animal products is essential
• Must have experience in compiling dossiers for Act 36 registrations and experience in writing protocols would be an advantage
• Experience or understanding of product development processes will be ideal
• Must be computer literate and have good communication skills

• Managing the regulatory process, including dossier life cycle management, pre-registration coordination, and post registration dossier submission activities.
• Liaising with regulatory ministries and staying up to date with various guidelines and accreditations (GMP/GLP/SANAS/OECD/SANS/FAO/GHS).
• Processing product renewals with various ministries of Agriculture and update in-house files.
• Conducting market research on proposed products.
• Delivering presentations on potential product development and investment.
• Coordinating the new product development process.
• Preparing and coordinating 3rd party laboratories and trialist.
• Preparing stabilities in accordance to OECD guidelines.
• Preparing trials in accordance to OECD guidelines Stakeholder reporting.
• Developing scientific capabilities and understanding.
• Processing registration applications with SADC and Australasia.
• Compiling dossiers for stock remedies and agricultural remedies.
• Understanding and working with principles with open part of a DMF compilation.
• Understanding ministerial guidelines for stock remedies and agricultural remedies.
• Maintain the samples store for clients and in-house R&D.
• Manage samples for research and development, including ordering of samples, ensuring clients and laboratories have up to date samples, and dispatching and tracking samples from Pastel.
• Generating commercial invoices.

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