Johannesburg: Regulatory Affairs Administrator posted by OttoBauthentic

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.