Latest regulatory affairs Jobs

Senior Medical Director, Oncology Clinical Development - Lung

This role involves leading clinical development for oncology, specifically in lung cancer, by providing medical oversight across study design, execution, and data interpretation. The Senior Medical Director will guide safety monitoring, contribute to regulatory interactions, and mentor junior medical staff. The position requires deep expertise in oncology clinical trials and close collaboration with cross-functional teams and external experts.

GSK

Hybrid Permanent

Clinical Development Medical Director- Hepatology

Lead clinical development strategy and execution for hepatology assets within GSK’s Respiratory, Immunology & Inflammation Research Unit. Provide medical oversight across translational and clinical studies, design development plans and protocols, and guide decision-making for early-phase programs. Work cross-functionally to advance novel liver disease treatments from discovery through clinical proof of concept, leveraging biomarker and real-world data to inform development.

GSK United Kingdom US$202,500 – US$337,500 pa

Hybrid Permanent

Analyst, Quality Control, Microbiology

This role involves performing routine environmental monitoring, water sampling, and microbiological testing to support GMP quality control for mRNA products. The analyst will execute tests including sterility, bioburden, endotoxin, and TOC, while supporting method transfers, validations, and compliance with cGMP standards. The position requires strong documentation practices, collaboration with cross-functional teams, and active participation in quality systems such as investigations and audits.

Moderna

On-site Permanent

(Fixed Term) Laboratory Technician, Clinical Biomarker Laboratory, Immunoassay

This role involves hands-on execution of immunoassay development, qualification, and clinical sample testing to support Moderna's clinical trials. The technician will prepare reagents, conduct analyses, ensure data quality, and maintain compliance with regulatory standards in a laboratory setting. The position requires full-time on-site work with occasional overtime and is embedded in a collaborative, regulated environment focused on high-quality bioanalytical output.

Moderna

On-site Contract

Clinical Study Data Lead - London, UK

This role involves leading end-to-end clinical data strategy and delivery across multiple complex trials, ensuring high-quality, submission-ready data. The Clinical Study Data Lead collaborates with cross-functional teams to define data standards, drive database design and cleaning, and support regulatory submissions. Emphasis is placed on quality, compliance, risk mitigation, and continuous improvement within a hybrid work environment.

Novartis London, United Kingdom £49,140 – £91,260 pa

Director, HTA, Value & Evidence (HV&E) - Obesity

Lead the development and execution of global health economics and outcomes research (HEOR) strategies to support market access for Pfizer’s obesity treatments. Design and manage evidence generation studies, including economic models and real-world data, to inform payer and regulatory decisions. Collaborate with cross-functional teams to align clinical development with access requirements and ensure successful product launches.

Pfizer United States £176,600 – £294,300 pa

On-site Permanent

Director, HTA, Value & Evidence (HV&E) - Obesity

Lead the development and execution of global health economics and outcomes research (HEOR) strategies to support market access for obesity treatments. Design and manage global evidence generation activities, including economic modeling, real-world studies, and value dossiers, in close collaboration with cross-functional teams. Build partnerships with external experts and stakeholders to inform payer and regulatory decision-making and ensure patient access to Pfizer’s obesity portfolio.

Pfizer £176,600 – £294,300 pa

Remote Permanent

Director, Control Domain Owner

Lead the strategy and governance of the Control data domain for structured product quality submissions, defining standards for specifications, analytical procedures, and control strategies across R&D, Quality, Regulatory, and Manufacturing. Partner with data stewards and technology teams to implement digital specifications and ensure data is trusted, standardized, and submission-ready.

GSK Barnard Castle, United Kingdom €115,500 – €192,500 pa

Safety Scientist – SERM (Safety Evaluation and Risk Management)

This role involves leading safety evaluation and risk management for GSK’s pharmaceutical products, focusing on signal detection, safety reporting, and risk mitigation across clinical and post-marketing stages. The scientist will collaborate with cross-functional teams, contribute to global regulatory submissions, and ensure patient safety through rigorous data analysis and scientific interpretation. Work is conducted in a hybrid model with an eventual move to Cambridge.

GSK Barnard Castle, United Kingdom PLN 215,250 – PLN 358,750 pa

VP, Medicine Development Leader - Specialty Product Development

Lead the global development of a specialty medicine from clinical proof of concept to first-market approval, serving as the single point of accountability across a matrixed, cross-functional team. Define strategic vision, oversee clinical and regulatory planning, and make evidence-based go/no-go decisions. Engage with regulators, senior leadership, and external stakeholders to advance patient-focused drug development within GSK’s R&D strategy.

GSK United States £242,250 – £403,750 pa

Safety Scientist – SERM (Safety Evaluation and Risk Management)

A Safety Scientist in GSK's Safety Evaluation and Risk Management (SERM) team leads signal detection, safety evaluations, and risk management for pharmaceutical products across clinical and post-marketing stages. The role involves authoring regulatory safety documents, contributing to Risk Management Plans, and collaborating with cross-functional teams to ensure global patient safety. It emphasizes scientific rigor, data interpretation, and proactive risk communication within a matrix environment.

GSK United Kingdom PLN 215,250 – PLN 358,750 pa

Director, Description Domain Owner

Lead the strategy and governance of the Description data domain to enable structured regulatory submissions such as ICH M16 SPQS and IDMP. Define standards for product, material, and CMC description data across R&D, Global Supply Chain, Regulatory, and Quality functions. Partner with technology teams to implement data products in SAP PLM and other platforms, ensuring data is trusted, standardized, and fit for future digital regulatory requirements.

GSK United Kingdom

Hybrid Contract

VP, Medicine Development Leader - Specialty Product Development

This role leads the global development of a specialty medicine from clinical proof of concept through to regulatory approval, serving as the single point of accountability. The VP will build and lead a cross-functional matrix team, define strategic development plans, make evidence-based go/no-go decisions, and ensure alignment with GSK's R&D and commercial strategies. The position involves significant interaction with regulators, senior management, and external stakeholders to deliver differentiated medicines and support lifecycle management.

GSK £242,250 – £403,750 pa

VP, Medicine Development Leader - Specialty Product Development

Leads the global development of a medicine from clinical proof of concept to approval, serving as the single point of accountability. Builds and leads a cross-functional matrix team to define strategy, drive evidence generation, and support regulatory and lifecycle planning. Interfaces with senior leadership and external stakeholders to advance patient-focused medical solutions.

GSK £242,250 – £403,750 pa

Director, Description Domain Owner

Lead the strategy and governance of the Description data domain to enable structured regulatory submissions (SPQS/IDMP), defining standards, business requirements, and data products across R&D, Supply Chain, Regulatory, and Quality. Drive harmonisation of product and material data across global systems and stakeholders, ensuring compliance and future-readiness for digital regulatory capabilities.

GSK

Hybrid Contract