Regulatory Assistant
3 weeks ago
Job Descriptions:
- Coordinate requests, receipts and dispatch of product samples for registration.
- Recording and monitoring of all sample requests, receipts and dispatch. Monitor expired samples and prepare for disposal
- Coordinate with laboratory, production and other departments for registration requirements
- Consolidate and compile raw data, reference information and product technical specifications
- Prepare registration documents such as Certificate of Analysis, Test Methods, Packaging Stability and Storage Stability Testing and report writing, Compatibility Testing and report writing, as required
- Evaluate new products if license is required according to local regulation
- Source for 3rd party testing lab, check accreditation and qualification.
- Prepare Inventory forms for materials to be included in Navision system for sales, logistics, and purchasing
- Source for data and prepare registration dossiers according to country specific guidelines for submission to legislation authorities
- Prepare Safety Data Sheet (SDS) and GHS labels in accordance to Globally Harmonized System (GHS) standards
Job Requirements:
- Diploma / Nitec in Applied Chemistry, Biomedical Science, Biotechnology or any other science related discipline
- Experience in lab testing is an advantage
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