Regulatory Affairs Officer

Overview

In this Regulatory Affairs Officer role, you will support lifecycle maintenance and regulatory submissions for UK & Ireland, with a focus on oncology. You’ll collaborate with Global Regulatory Affairs and cross-functional teams to ensure compliance and timely licence maintenance. You’ll monitor regulatory developments, contribute to quality and document management, and help shape regulatory strategy. This position offers exposure to both marketed and pipeline oncology medicines within a values-driven, fast-paced environment.

Responsibilities

• Support regulatory lifecycle maintenance activities in the UK and Ireland
• Coordinate and implement approved regulatory changes, including SmPCs, PILs, labels and packaging
• Support responses to MHRA and HPRA requests
• Maintain regulatory databases, submission trackers and document management systems
• Collaborate with Global Regulatory Affairs and cross-functional stakeholders on regulatory strategy
• Contribute to licence maintenance and optimisation across oncology and specialty care
• Monitor UK & Irish regulatory developments and conduct competitor intelligence
• Assess regulatory changes impacting business and patients
• Ensure compliance with regulatory requirements, GxP, and company procedures
• Support controlled document management, quality systems, change controls, deviations, CAPAs and inspection readiness
• Assist with complaint handling and investigation activities
• Support KPI generation and compliance reporting
• Partner with Medical Affairs, Pharmacovigilance, Quality, Supply Chain, Commercial and Global Regulatory Affairs
• Support continuous improvement within Regulatory Affairs and Quality

Key requirements

• Degree in Life Sciences or related scientific discipline
• Experience in the pharmaceutical industry
• Understanding of the UK medicines regulatory framework
• Basic knowledge of GxP
• Strong organisational and project management skills
• Excellent written and verbal communication
• Ability to manage multiple priorities and tight deadlines
• Strong attention to detail and commitment to quality
• Desirable: experience supporting MHRA submissions; Regulatory Operations; Quality Management Systems; knowledge of deviations, CAPAs and change controls; TOPRA membership or progress towards

• proactive
• collaborative
• detail-oriented
• Regulatory databases
• Submission trackers
• Document management systems

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