Latest regulatory affairs Jobs

Product Manager - Regulatory Vault

Are you passionate about making impactful contributions to the world of medicines and vaccines? GlaxoSmithKline (GSK) invites you to join our dynamic R&D Digital and Tech Team as a Product Manager - Regulatory Vault. In this pivotal role, you will...

GSK United Kingdom

Senior CMC Regulatory Strategy Manager

Leads CMC regulatory strategy for biopharmaceutical development and lifecycle management, coordinating submissions and ensuring compliance with global regulations. Works across cross-functional teams to address complex regulatory challenges and support continuous supply. Focuses on risk mitigation, process improvement, and influencing regulatory decisions in a matrix environment.

GSK Stevenage, United Kingdom €90,000 – €150,000 pa

Hybrid Permanent

Global Labelling Manager, Content (Neuroscience)

The Global Labelling Manager, Content will lead the development and maintenance of high-quality global labelling documents for pharmaceutical products. Key responsibilities include organising cross-functional discussions, conducting research on competitor labels, and ensuring compliance with regulatory standards across different markets.

Novartis

Hybrid Permanent

Global Labelling Associate Director, Content (Oncology)

This role involves developing and maintaining global labelling strategies and core documents for oncology products. You will lead cross-functional discussions, present proposals to governance bodies, and ensure compliance with regulatory requirements across global markets.

Novartis

Hybrid Permanent

Director, Medical Insights

The Director, Medical Insights role involves shaping and implementing strategies to enhance Pfizer's medical insights capabilities. Key responsibilities include developing insights frameworks, driving alignment across medical affairs, and leveraging advanced analytics and AI to translate complex data into actionable insights that inform strategic decisions.

Pfizer

On-site Permanent

Director, Medical Insights

The Director, Medical Insights role involves shaping and implementing Medical Insights processes, collaborating with various stakeholders to generate actionable insights, and embedding these insights into medical decision-making. The role focuses on advanced analytics, AI, and emerging technologies to inform Pfizer's medical strategies and improve the value of medical insights.

Pfizer

On-site Permanent

Manager, Global Regulatory Science CTA

This role involves leading the operational execution of Clinical Trial Applications (CTAs) globally, outside the US, with a focus on the UK regulatory landscape. Responsibilities include managing CTA submissions, ensuring regulatory compliance, coordinating with CROs, and leveraging advanced digital tools to enhance submission efficiency.

Moderna Poland

On-site Permanent

Manager, Global Regulatory Science CTA

This role involves leading the operational execution of Clinical Trial Applications (CTAs) globally, outside the US, with a focus on the UK regulatory landscape. Responsibilities include managing CTA activities, ensuring regulatory compliance, coordinating with CROs, and leveraging advanced digital tools to enhance submission efficiency.

Moderna

On-site Permanent

Director Biostatistics

The Director of Biostatistics leads the statistical aspects of clinical development programs, ensuring robust data analysis and regulatory compliance. They collaborate with cross-functional teams, manage external partners, and represent Biostatistics in regulatory interactions.

CSL

Hybrid Permanent

Director Biostatistics - Hematology

The Director of Biostatistics leads the statistical aspects of clinical development programs, ensuring robust study design, data analysis, and regulatory submissions. They collaborate closely with cross-functional teams and regulatory authorities to drive the success of clinical trials and ensure high-quality statistical insights.

CSL

Hybrid Permanent

Senior Director of Operational Technology (Operations)

This role involves leading the execution of OT strategy across AstraZeneca's global manufacturing network, ensuring alignment with business priorities and improving reliability, safety, and compliance. Key responsibilities include lifecycle management, risk mitigation, capability building, and regulatory readiness.

AstraZeneca Macclesfield, United Kingdom

On-site Permanent

Director, Alliance Management

This role involves leading strategic partnerships with CROs, ensuring governance, performance, and relationship management. The Director will collaborate globally, drive continuous improvement, and support cross-functional teams at AstraZeneca's Cambridge Biomedical Campus.

AstraZeneca Cambridge, United Kingdom

Hybrid Permanent

Biomedical Engineer

This role involves hands-on maintenance and repair of laboratory biomedical equipment, including stainers, cover slippers, and Roche Ultra systems, alongside managing CMMS operations using Qualer. The engineer ensures regulatory compliance, supports lab staff with equipment best practices, and coordinates vendor services to maintain high equipment uptime across a site with approximately 500 machines. Key responsibilities include preventive maintenance, calibration, troubleshooting, and accurate documentation within a regulated R&D and diagnostics environment.

KEMIO Consulting LTD Babraham, Cambridgeshire, United Kingdom £40,000 – £55,000 pa

On-site Permanent

Senior QA Validation Engineer

This role involves leading software verification and validation for safety-critical systems within a regulated environment, ensuring compliance with quality standards across the development lifecycle. The engineer will design test strategies, develop automated test frameworks, and maintain traceability between requirements and testing activities. Collaboration with cross-functional teams is essential to support regulatory documentation, risk management, and continuous process improvement.

SoCode Impington, Cambridgeshire, United Kingdom £80,000 – £100,000 pa

On-site Permanent

Junior AI Healthcare Specialist

This role involves developing and deploying AI and machine learning solutions in healthcare settings, focusing on improving clinical decision-making and operational efficiency. The specialist will work with multidisciplinary teams to build predictive models and generative AI applications using real-world healthcare data. Emphasis is placed on ethical, compliant, and reliable AI systems that integrate with existing healthcare infrastructure.

Global Tech Recruitment London, United Kingdom £38,000 – £40,000 pa

Hybrid Permanent