Regulatory Affair Pharmacist

Pharma Dynamics

Western Cape, South Africa

Permanent

Jul 7

Manage the registration process for allocated therapeutic categories for new and existing products, including liaison with the relevant Health Authorities and third parties ABLE TO UNDERTAKE ALL OF THE RESPONSIBILITIES BELOWProduct registration Conduct due diligence on new dossiers from overseas and local suppliers and compile for submission as and when required Liaise with SAHPRA and export Regulatory Authorities on behalf of Pharma Dynamics on new and existing queries as and when required Compile, sign and submit all dossier submissions as required Identify and maintain updates on existing products based on SAHPRA guidelines and allocated priorities Interact on a regular basis with overseas affiliates, third parties and contractors on dossier related activities Compile and submit all SAHPRA recommendations, Safety Updates and amendments within agreed and specified time limits Conduct due diligence on SAHPRA dossiers in order to compile dossiers for submission in neighboring countries, as and when required Assist with the identification of variations, and maintenance of dossiers in neighboring countries, in line with South African dossier General management of dossiers and printed packaging components in submitted countries. Supervise/manage/coach staff complement and related activities, if/when necessaryTechnical /Compliance activities Assist with technical queries internally and with the guidance of line management, externally Assist with answering relevant Pharmacovigilance and Technical queries Assists with review and approval of batch release documents as and when required Assists with periodic internal audits Manage and monitor the Change Control Process effectively Liaise with SAHPRA on registration status and technical queriesPackaging material Review and facilitate approval of printed packaging components Ensure all printed material, complies with the Marketing Code of Conduct and SAHPRA requirementsDocument management Ensure the EDMS is current and up to date and in line with submitted dossiers.General Perform any other duties as per changes in operational requirements of the department. Perform any other duties as requested

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Pharma Dynamics

Pharma Dynamics is a leading pharmaceutical company. We are one of South Africa's largest generic medicine providers and the country's leading provide...

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