Regulatory Digital Transformation Lead

PSMP; Gauteng; On-site; ZAR 1,200,000 - 1,800,000; Full time

Job summary

PSMP, a pharmaceutical company in South Africa, seeks 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 translates business requirements into digital solutions that strengthen compliance, operational efficiency, portfolio visibility, lifecycle management and data-driven

Qualifications

• Biomed/Pharma degree and regulatory knowledge required.
• Experience with regulatory information management systems beneficial.
• Strong analytical and problem-solving skills required.
• Ability to lead cross-functional teams and manage projects.

Responsibilities

• Develop and maintain dashboards and analytics to show submission performance and KPIs.
• Lead requirements gathering, system design reviews and change-control activities.
• Drive digital transformation and automation initiatives across multiple regulatory domains.
• Oversee regulatory data governance and reporting integrity.
• Lead troubleshooting for complex system issues and implement corrective actions.
• Support and optimize RIMS, workflow platforms, and regulatory document platforms.
• Partner with Digital, IT and cross-functional teams to evaluate ROI and compliance benefits.
• Lead ownership and lifecycle management of regulatory, pharmacovigilance and medical digital systems.
• Manage workload and develop team members.

Skills

Regulatory affairs

Data governance

Analytics

Project management

Leadership

Education

BPharm

BSc or higher postgraduate degree

Tools

RIMS

Workflow platforms

eCTD systems

Job description

PSMP, a pharmaceutical company in South Africa, seeks 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 translates business requirements into digital solutions that strengthen compliance, operational efficiency, portfolio visibility, lifecycle management and data-driven