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Johannesburg: Regulatory Affairs Administrator posted by OttoBauthentic

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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
View Job  Cape Town: Rx Pharmaceutical Sales Rep - WC posted by OttoBauthentic

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.



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