Regulatory Affairs Administrator

OttoBauthentic; Johannesburg; On-site; ZAR 200 000 - 300 000; Full time

Job summary

A compliance-focused organization in Johannesburg seeks an individual to provide administrative, operational, and regulatory support. The role involves assisting with daily operations, managing SAHPRA documentation, and ensuring compliance with regulatory standards. Ideal candidates should have a Matric Certificate and advanced skills in Microsoft Office. The position demands good communication skills and the ability to work under pressure in a dynamic environment. A minimum of 1 year experience in Regulatory Affairs is desirable.

Qualifications

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

Responsibilities

• Provide administrative, operational, and regulatory support to the department.
• Assist with day-to-day operations and administrative tasks.
• Compile permit applications for submission to SAHPRA.
• Build and maintain effective communication channels with SAHPRA representatives.

Skills

Advanced proficiency in Microsoft Office

Strong Excel skills

Proficiency in Microsoft Word

Proficiency in Outlook

High level of computer literacy

Education

Matric Certificate

Job description

Main Purpose of Job

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

Duties & Responsibilities

• 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

Education

• Matric Certificate.

Skill Requirement

• Advanced proficiency in Microsoft Office.
• Strong Excel skills.
• Proficiency in Microsoft Word.
• Proficiency in Outlook.
• High level of computer literacy.

Behavioural Qualities

• Deadline-driven.
• Strong attention to detail.
• Good planning and organizing skills.
• Effective communication skills.
• Strong time management abilities.
• Ability to work well under pressure.
• Self-initiated and proactive.
• Cooperative and team oriented.
• Conscientious and responsible.

Desirable Skills & Experience

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