Regulatory Affairs Systems & Data Analyst

Job Purpose

To support the Regulatory Affairs (RA), Medical Affairs (MA), Pharmacovigilance (PV) department by managing and optimizing digital systems, data workflows, and process automation. This role combines regulatory knowledge with strong IT capabilities to ensure accurate data management, efficient tracking of submissions, and compliance reporting. The incumbent will leverage technology to enhance operational efficiency, enable advanced analytics, and support RA, Medical and PV transformation aligned with business strategy

Key Responsibilities

• Systems & Data Management:

• Maintain and optimize RA, MA & PV databases, dashboards, and SharePoint sites.
• Ensure accurate data capture, integrity, and timely updates for regulatory submissions and life-cycle management.
• Implement automation tools and digital solutions to streamline RA, MA & PV processes.

• Data Analytics & Reporting:

• Collect, analyse, and visualize RA, MA & PV data to provide actionable insights.
• Develop and maintain reporting tools for monthly and ad hoc regulatory metrics.
• Support predictive analytics for submission timelines and compliance trends.

• Process Improvement & Digital Transformation:

• Identify opportunities for process automation and system enhancements.
• Collaborate with IT, RA, MA & PV teams to implement new technologies and workflows.
• Act as a key contributor to RA, MA & PV transformation projects.

• Stakeholder Collaboration:

• Work closely with RA, MA, PV and IT teams to ensure seamless integration of systems.
• Support communication and knowledge sharing across cross-functional teams.

Technical skills

• Proficiency in data management tools (Excel, Power BI, SQL).
• Experience with SharePoint administration and document management systems.
• Familiarity with regulatory submission platforms (eCTD or similar).
• Understanding of process automation tools (e.g., Power Automate).
• Strong analytical and problem-solving skills.

Qualifications

• Education: Diploma/Degree in Information Technology, Computer Science, or related field (Regulatory experience advantageous).
• Experience: 1–2 years in IT systems support, data analytics, or process automation (exposure to regulatory or healthcare environment preferred).
• Soft Skills: Attention to detail, resilience, collaborative approach, time management, and excellent communication skills.

Key dimensions

• Ownership of RA, MA & PV reporting systems and dashboards.
• SharePoint maintenance and optimization.
• Support strategic digital initiatives within RA, MA & PV.
• Chair meetings for IT-related RA, MA & PV projects.