Regulatory Affairs Administrator

Staff Unlimited Recruitment; Johannesburg; On-site; ZAR 200 000 - 300 000; Full time

Job summary

A leading recruitment agency in Johannesburg is seeking a candidate to provide administrative and regulatory support. The successful applicant will manage day-to-day operations, ensure compliance with SAHPRA, GMP, and ISO 13485 regulations, and assist with various documentation tasks. Proficiency in Afrikaans and advanced skills in Microsoft Office, especially Excel, are essential. This role offers an opportunity to work in a dynamic environment within the regulatory affairs sector.

Qualifications

• Matric Certificate is required.
• Advanced Microsoft Office proficiency necessary.
• Strong Excel skills required.
• Fluency in Afrikaans to manage translations is essential.

Responsibilities

• Provide administrative support ensuring compliance with regulations.
• Assist with daily operations and administrative tasks.
• Compile applications and documentation for SAHPRA.
• Build and maintain communication with SAHPRA representatives.

Skills

Fluency in Afrikaans

Advanced Microsoft Office proficiency

Strong Excel skills

Proficiency in Microsoft Word

Proficiency in Outlook

High level of computer literacy

Education

Matric Certificate

Job description

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 relatie & 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 badass 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.