Senior Regulatory Affairs Scientist

Product/Dossier Life Cycle Management

• Conduct due diligence on received change controls, variation packages, and dossiers pertinent to, but not restricted to, LCM of products within the registered SAHPRA portfolio.   


• Compile and submit responses to SAHPRA recommendations, Safety Updates and variations, within agreed and specified time limits.


• Compilation of dossier modules related to submission of variations and/or SAHPRA responses when not supplied by third party stakeholders.


• Identify and maintain updates on registered products based on SAHPRA guidelines and allocated priorities.


• Interact on a regular basis with PD departments, overseas affiliates, third parties and contractors on necessary regulatory activities.


• Liaise with SAHPRA on behalf of Pharma Dynamics on new and existing queries, as and when required.


• Assist with maintaining app...

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