Regulatory Affairs Administrator

2 days ago

Johannesburg, South Africa OttoBauthentic Full time

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.

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