Regulatory Affairs Scientist (Southern Suburbs (Cape)

Job Location : , South Africa, South Africa

Application Deadline : February 09, 2026

Description

ABLE TO UNDERTAKE ALL OF THE RESPONSIBILITIES BELOW

Product / dossier life cycle management

• Conduct due diligence on received change controls, variation packages, and dossiers pertinent to, but not restricted to, life cycle management of products within the registered SAHPRA portfolio.
• Compile and submit responses to SAHPRA recommendations, Safety Updates and variations, within agreed and specified time limits, with a focus on allocated phased in approach on complexity of submissions
• 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), pertaining to life cycle management of products, to streamline departmental workflow.
• Maintain the department’s online apps (eg. CCP database, docuBridge etc) as per official SOPs and / or working instructions.
• Assistance with the artwork process to finalise printed packaging, as / when required.
• Supervise / manage / coach staff complement and related activities, if / when necessary.

Technical / Compliance activities

Packaging material

Document management

General

Requirements

PRE-REQUISITES