Regulatory Business Analyst

Regulatory Business Analyst

Global Digital Transformation Regulatory Systems Hybrid Working

Our client is a global organisation undertaking a major digital transformation across its Regulatory, Quality and R&D functions.

We are looking for an experienced Regulatory Business Analyst / Senior Business Analyst with strong knowledge of regulatory processes and systems. Working closely with Regulatory, Quality and IT teams, you will translate complex business requirements into effective digital solutions, while developing into a Technical Product Owner role.

Key Responsibilities

• Lead requirements gathering, discovery sessions and stakeholder interviews.
• Analyse and map regulatory processes, workflows and data requirements.
• Translate business and regulatory needs into user stories and acceptance criteria.
• Support product backlog management, prioritisation and roadmap development.
• Work with technical teams and stakeholders through solution delivery, testing and validation.
• Support continuous improvement and digital transformation across Regulatory and Quality systems.

About You

• Strong experience as a Senior Business Analyst, Regulatory Business Analyst or Business Systems Analyst.
• Experience within a regulated environment, ideally pharmaceutical, life sciences, medical devices, FMCG or cosmetics.
• Experience working with Regulatory, Quality, R&D or Product teams.
• Knowledge of Regulatory Information Management (RIM), PLM or QMS systems.
• Experience with Veeva RegulatoryOne/Vault is desirable, but comparable regulatory systems experience will be considered.
• Strong requirements gathering, process mapping and stakeholder management skills.
• Agile experience, including user stories and backlog management.
• GxP/FDA or Computer System Validation experience would be advantageous.

This is an excellent opportunity for a strong Regulatory Business Analyst to join a global transformation programme and develop into a Technical Product Owner, working across regulatory, quality and digital technology.

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