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 applicant interface of SAHPRA apps (eg. Engagement Portal, NDS), perta...