Latest regulatory affairs Jobs

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Clinical Development Senior Medical Director - Vascular

Lead clinical development for vascular programs across early and late-phase trials, designing studies and translational plans to advance medicines for cardiovascular disease. Collaborate with cross-functional teams to shape clinical strategies, ensure regulatory compliance, and drive patient-focused innovation within GSK’s R&D pipeline.

GSK
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Clinical Development Senior Medical Director - Vascular

Lead clinical development for vascular programmes across early and late phases, designing studies and translational plans to advance medicines for cardiovascular disease. Collaborate with cross-functional teams to shape clinical strategies, ensure patient safety, and drive innovation in drug development. Play a key role in regulatory interactions, trial oversight, and identifying transformative opportunities in vascular medicine.

GSK
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Scientist, Clinical Biomarker Laboratory, Immuno-Assays - Cell Based

This role involves leading the development, qualification, and execution of complex cell-based immunoassays to support Moderna’s clinical trials across multiple therapeutic areas. The scientist will generate high-quality, regulatory-compliant data using advanced immunological techniques and serve as a subject matter expert within cross-functional teams. Emphasis is placed on innovation, scientific rigor, and integration of emerging technologies including digital and AI-enabled workflows in a GCP/GLP-regulated environment.

Hybrid Permanent
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Senior Automation Engineer, Laboratory Automation & Biobanking

This role involves designing and optimizing automated laboratory workflows for biomarker testing and sample management using advanced liquid handling systems like Hamilton platforms. The engineer will lead integration of automation with data systems, develop data pipelines, and support AI-enhanced laboratory operations while ensuring compliance with GLP/GCLP standards. Collaboration with digital, QA, and vendor teams is key to delivering scalable, high-throughput solutions in a regulated clinical environment.

Hybrid Permanent
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Platform Equipment Lead (Metrology)

This role involves leading metrology and calibration systems at GSK’s Ware site, ensuring compliance with GMP and engineering standards. You’ll oversee calibration services, lead technical investigations, improve measurement systems, and support capital projects using data-driven insights. The position offers technical leadership, cross-functional collaboration, and strategic impact within a regulated pharmaceutical manufacturing environment.

GSK East Hertfordshire, United Kingdom
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Sterility Assurance Senior Expert

This role involves leading sterility assurance projects and overseeing facility compliance with regulatory standards in a pharmaceutical manufacturing environment. The individual will drive contamination control strategies, ensure adherence to cGMP and industry regulations, and act as the primary point of contact during audits. Collaboration with operations and quality teams is essential to integrate sterility assurance into manufacturing processes and support continuous improvement.

GSK Barnard Castle, United Kingdom
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Device and Packaging Technologist

This role provides technical support for device assembly and packaging operations at GSK’s Barnard Castle site, focusing on sterile, intranasal, dermatological, and combination products. The technologist will lead investigations, support new product introductions, drive process improvements, and ensure compliance with GMP and regulatory standards across internal and external manufacturing sites.

GSK Barnard Castle, United Kingdom
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Head of RTSM (Randomization and Trial Supply Management)

Leads the design and delivery of randomization and clinical trial supply strategies across global clinical trials, ensuring patient-focused solutions and compliance. Manages cross-functional teams and vendors, drives process improvements, and ensures reliable supply availability. Focuses on quality, efficiency, and integration with clinical systems across phases I–IV.

GSK Stevenage, United Kingdom
Hybrid Permanent
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Clinical Programmer/Analyst

The role involves developing, testing, and validating programming code to transform and analyze clinical and real-world data for use in regulatory submissions and scientific reporting. You'll collaborate with statisticians and data scientists to ensure outputs meet CDISC standards and regulatory requirements, while contributing to programming best practices within an agile environment. The position emphasizes code quality, compliance with GxP and ICH guidelines, and the use of modern tools and methodologies in a hybrid work setting.

GSK Stevenage, United Kingdom
Hybrid Permanent
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Quality Governance & Partnership Senior Specialist

This role involves managing quality governance systems for raw materials and suppliers at GSK’s manufacturing site. The specialist ensures compliance with pharmaceutical regulations, oversees supplier quality workflows, handles change controls and audits, and maintains documentation for material specifications and supplier agreements. The position plays a key role in maintaining supply chain integrity and regulatory compliance within a highly regulated biopharma environment.

GSK Barnard Castle, United Kingdom
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Statistics Leader / Associate Director of Statistics

This role involves providing statistical leadership across oncology clinical development, from early-phase trials to regulatory submissions. The candidate will lead study design, analysis, and interpretation using advanced methods like Bayesian approaches and real-world data integration. They will collaborate with cross-functional teams to deliver robust statistical insights that inform key development decisions in a global biopharma environment.

GSK Stevenage, United Kingdom PLN 326,250 – PLN 543,750 pa
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Head of RTSM (Randomization and Trial Supply Management)

Lead the design and delivery of Randomization and Trial Supply Management (RTSM) strategies across global clinical trials, ensuring reliable supply and randomization systems for patient-focused studies. Partner with cross-functional teams and external vendors to optimize processes, ensure compliance, and support clinical trial execution from Phase I–IV. This role emphasizes leadership in process improvement, team development, and integration of RTSM within broader clinical operations.

GSK United States
Hybrid Permanent
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SERM Scientific Director

Leads safety evaluation and risk management for GSK's oncology assets in clinical development, providing scientific expertise to assess and communicate safety risks globally. Works cross-functionally to shape safety strategy, support regulatory submissions, and ensure patient protection. Focuses on signal detection, risk assessment, and strategic decision-making in a matrix environment.

GSK £111,750 – £186,250 pa
On-site Permanent
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Clinical Programmer/Analyst

The Clinical Programmer/Analyst designs, builds, and reviews programming solutions to transform clinical and real-world data into reliable, compliant outputs. Working closely with statisticians and data scientists, the role involves developing code for data transformation, analysis, and reporting in line with CDISC standards (SDTM, ADaM) and regulatory requirements. The position supports agile delivery of high-quality datasets, tables, listings, and figures while promoting programming best practices and innovation within a collaborative, cross-functional environment.

GSK United Kingdom
Hybrid Permanent
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Statistics Leader / Associate Director of Statistics

Lead statistical strategy for oncology clinical development, from study design through regulatory submission, using advanced methods like Bayesian approaches and real-world data. Partner with cross-functional teams to deliver robust analyses and influence key decisions. Drive innovation in trial design and evidence generation within a global biopharma environment.

GSK United States £150,150 – £250,250 pa