Systems, Analytics & Digital Transformation Manager

Our client in the pharmaceutical industry is seeking a Systems, Analytics & Digital Transformation Manager to provide strategic ownership and governance of digital systems, automation platforms, data analytics and business transformation initiatives across Regulatory Affairs, Pharmacovigilance and Medical Affairs. The role will translate business requirements into digital solutions that strengthen compliance, operational efficiency, portfolio visibility, lifecycle management and data-driven decision-making.

KEY RESPONSIBILITIES

• Develop and maintain dashboards, executive reporting and analytics to provide visibility of submission performance, lifecycle management, compliance metrics and business KPIs.

• Lead business requirements gathering, system design reviews, solution deployment, upgrades, testing, validation and change-control activities.

• Drive digital transformation, process optimisation and automation initiatives using workflow technologies, automation platforms and AI-enabled solutions.

• Manage regulatory data governance, data quality, reporting integrity and business continuity across interconnected systems.

• Lead troubleshooting and root-cause investigations for complex system, workflow, integration and data-related issues, implementing sustainable corrective actions.

• Support and optimise Regulatory Information Management Systems (RIMS), workflow platforms, eCTD systems, reporting solutions, product databases and regulatory document platforms.

• Partner with Digital, IT and cross-functional teams to implement technology solutions and evaluate opportunities based on ROI, productivity and compliance benefits.

• Lead the ownership, governance, implementation and lifecycle management of regulatory, pharmacovigilance and medical digital systems and platforms.

• Manage and develop assigned team members, including workload allocation, performance management, training and knowledge transfer.

• Maintain awareness of emerging regulatory and digital technologies and support the evaluation and implementation of future solutions, including AI and automation.

MINIMUM REQUIREMENTS

• BPharm, BSc or higher postgraduate scientific degree.

• Minimum 4 years’ experience within the Regulatory Affairs function.

• Proficient knowledge of the Medicines and Related Substances and applicable SAHPRA regulations/guidelines, GMP/GLP/GCP and EMA requirements.

• Proficient knowledge of the Pharmacy Acts, related regulations, Good Pharmacy Practice guidelines and the Code of Conduct of a pharmacist.

• Advanced understanding of Regulatory Information Management Systems (RIMS), workflow platforms, automation technologies and reporting solutions.

• Strong understanding of system architecture, system integrations and data governance concepts.

• Demonstrated expertise in root-cause analysis, troubleshooting and resolving complex business system issues.

• Experience supporting large-scale system implementations, migrations, testing and validation activities.

• Ability to translate technical system issues into business impacts and solutions.

• Strong analytical and problem-solving skills, project management capability and the ability to lead a team.

• Strong understanding of system architecture, IT, system integrations and data governance concepts.

The ideal candidate will be detail-oriented, resilient and collaborative, with strong analytical, problem-solving, project management and communication skills. They should be comfortable operating at the intersection of Regulatory Affairs and technology, able to manage multiple interconnected systems, influence stakeholders, translate business needs into practical digital solutions and lead teams through system, process and technology change. If you are an experienced Regulatory Affairs professional with strong systems, analytics and digital transformation expertise ready to drive technology-enabled regulatory operations, apply now using the link below.