To provide administrative, operational, and regulatory support to ensure the efficient functioning of the department and compliance with SAHPRA, GMP, and ISO 13485 requirements.

Key Performance Areas

Operations and Administration Support

· Assist with day-to-day operations and administrative tasks of the company.

· Control the flow of promotional materials and master documentation.

· Complete assigned sections of registration dossier for submission to SAHPRA.

· Prepare and type resolution templates.

· Order product samples for laboratory analysis.

· Monitor updates and changes on SAHPRA and related websites.

· Update and maintain departmental Smartsheet plans.

· Maintain current knowledge of SAHPRA requirements.

· Prepare expense requisitions for the Finance Department.

· Prepare documents for uploading to supplier sites; download and systematically store supplier documents on the server.

· Assist with Reception duties when required.

· Perform any additional administrative tasks assigned by management.

· Fluency in Afrikaans to manage and review of English to Afrikaans translations

SAHPRA Submissions and Regulatory Support

· Compile permit applications for submission to SAHPRA.

· Review master documentation (BMRs, BPRs, API and FP specifications, etc.) in compliance with GMP and ISO 13485 standards.

· Compile assigned sections of generic registration dossiers.

· Submit third-party Site Master Files to SAHPRA.

· Use DocuBridge to source working documents and prepare submissions for publishing.

· Manage and maintain activities on the SAHPRA RIMS Portal.

Communication and Coordination

· Build and maintain effective communication channels with SAHPRA representatives to support positive stakeholder relationships.

· Establish and maintain contact with manufacturers to obtain information timeously.

· Compile and update SOPs as required by SAHPRA and ISO 13485, within agreed timeframes.

· Proofread and verify artwork to ensure compliance with approved dossier labelling and regulatory requirements.

Minimum Requirements

• Matric Certificate.

· Advanced proficiency in Microsoft Office.

· Strong Excel skills.

· Proficiency in Microsoft Word.

· Proficiency in Outlook.

· High level of computer literacy.

Minimum 1 year exposure in Regulatory Affairs will be an advantage.