Regulatory Affairs Administrator - Jhb

MAIN JOB FUNCTION

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

• 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

• Compile permit applications for submission to SAHPRA.
• Review master documentation (BMRs, BPRs, API and FP specifications, etc.) in compliance with GMP and ISO standards.
• Compile assigned sections of generic registration dossiers.
• Submit third-party Site Master Files to SAHPRA.
• Use Docu Bridge to source working documents and prepare submissions for publishing.
• Manage and maintain activities on the SAHPRA RIMS Portal.

• 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 , within agreed time frames.
• Proofread and verify artwork to ensure compliance with approved dossier labelling and regulatory requirements.

Matric Certificate.

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