Systems, Analytics & Digital Transformation Manager

About the role

The role is based in Gauteng and focuses on strategic ownership and governance of digital systems, automation platforms, data analytics and business transformation initiatives across Regulatory Affairs, Pharmacovigilance and Medical Affairs in a pharmaceutical environment.

Key responsibilities

• Develop and maintain dashboards, executive reporting and analytics for submission performance, lifecycle management and compliance metrics.
• Lead business requirements gathering, system design, solution deployment, upgrades, testing, validation and change‑control activities.
• Drive digital transformation, process optimisation and automation using workflow technologies, automation platforms and AI‑enabled solutions.
• Manage regulatory data governance, data quality, reporting integrity and business continuity across interconnected systems.
• Support and optimise Regulatory Information Management Systems (RIMS), eCTD systems, workflow platforms and product databases.

Required profile

• BPharm, BSc or higher postgraduate scientific degree.
• Minimum 4 years’ experience within the Regulatory Affairs function.
• Proficient knowledge of SAHPRA regulations, GMP/GLP/GCP, EMA requirements and Pharmacy Acts.
• Strong analytical, problem‑solving, project management and team‑leadership capabilities.

Required skills

• Regulatory Information Management Systems (RIMS) and eCTD platforms.
• Workflow and automation platforms, including AI‑enabled solutions.
• System architecture, integrations and data governance concepts.
• Root‑cause analysis, troubleshooting and large‑scale system implementation.
• Testing, validation and change‑control processes.