Latest regulatory affairs Jobs

Senior Medical Director, Oncology Clinical Development - Lung

This role involves leading oncology clinical development for lung cancer programmes, providing medical oversight across study design, execution, and data interpretation. The Senior Medical Director ensures patient safety, guides cross-functional teams, and represents the programme in regulatory and scientific forums. Based on-site with a future relocation to Cambridge, UK, the position emphasizes strategic clinical leadership within a global biopharma environment.

GSK

On-site Permanent

Senior Medical Director, Oncology Clinical Development - Lung

This role involves leading oncology clinical development for lung cancer programmes, providing medical oversight across study design, execution, and data interpretation. The Senior Medical Director ensures patient safety, contributes to regulatory engagements, and mentors medical teams within a cross-functional environment. The position integrates physician expertise into clinical strategy and external scientific forums, focusing on advancing care in high unmet need cancers.

GSK

On-site Permanent

Audit Lead

This role leads GMP/GDP audit strategy and execution for key technology areas such as sterile biologics, medical devices, or small molecule manufacturing within Pfizer’s global supply network. The Audit Lead conducts complex audits at internal sites and external vendors, ensures compliance with global regulations, and drives continuous improvement in quality systems. They provide expert guidance, coach auditors, and collaborate across functions to address risks and support inspection readiness.

Pfizer US$162,900 – US$271,500 pa

Remote Permanent

Senior Manager, Packaging Engineering

Lead the technical development and implementation of a new labeling and secondary packaging operation at Moderna's Harwell site, ensuring compliance with GxP and safety standards. Establish maintenance strategies, lead capital projects, and drive continuous improvement using engineering excellence principles. Work closely with global teams and support digital integration in a high-growth biotech environment.

Moderna Oxford, United Kingdom

Hybrid Permanent

(Fixed Term) Scientist, Immunogenicity, Bioanalytical and Molecular Assays

This role involves designing and executing bioanalytical and immunogenicity strategies to support mRNA-based therapeutic development. The scientist will lead assay development for clinical programmes using platforms like ELISA, MSD, and cell-based methods, ensuring regulatory compliance and robust data generation. The position emphasizes collaboration across multidisciplinary teams and integration of digital tools and AI to advance Moderna's pipeline.

Moderna Oxford, United Kingdom

On-site Contract

Head of Neurodegeneration, Translational Medicine

This role involves leading the translational strategy for neurodegenerative disease programs from discovery through early clinical development. The Head of Neurodegeneration will guide global cross-functional teams, design first-in-human and Phase IIa studies, and shape biomarker and patient-relevant endpoint strategies. They will act as a scientific thought leader while engaging with regulatory authorities, KOLs, and internal stakeholders to advance therapeutic innovation in a hybrid work environment.

Novartis London, United Kingdom

Global Program Safety Lead - CRM

This role involves leading the end-to-end safety strategy for priority pharmaceutical programs in the Cardio Renal Metabolism (CRM) therapeutic area, from development through lifecycle management. The individual will serve as the scientific safety leader, driving safety governance, benefit-risk assessments, and regulatory interactions, while mentoring teams and embedding safety insights across global functions. It requires deep expertise in pharmacovigilance, cross-functional leadership, and clear communication of complex safety data.

Novartis London, United Kingdom £83,510 – £155,090 pa

Director, HTA, Value & Evidence (HV&E), Obesity Early Pipeline

Lead the development and execution of global health economics and outcomes research (HEOR) strategies for obesity and internal medicine products in early clinical development. Design and oversee real-world evidence studies, economic modeling, and patient-reported outcomes to support market access and reimbursement. Collaborate with cross-functional teams and external stakeholders to ensure evidence generation aligns with global payer and regulatory requirements.

Pfizer United States

Director, AI/ML MIDD Oncology Clinical Pharmacology, Modeling and Simulation

Lead and execute model-informed drug development strategies in oncology, applying advanced pharmacometric and AI/ML techniques to optimize dose selection, trial design, and regulatory submissions. Work across multidisciplinary teams to drive quantitative decision-making in clinical pharmacology and contribute to the development of innovative cancer therapies.

GSK United States £188,100 – £313,500 pa

Director, Description Domain Owner

Lead the strategy and governance of the Description data domain to enable structured regulatory submissions (SPQS) and digital regulatory capabilities. Define standards, business requirements, and data products across R&D, Supply Chain, Regulatory, and Quality functions, ensuring harmonized product and material data. Partner with technology teams to implement scalable solutions in platforms like SAP PLM.

GSK €115,500 – €192,500 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 in clinical development and post-marketing. The role involves authoring regulatory safety documents, contributing to Risk Management Plans, and collaborating with cross-functional teams to ensure patient safety. It requires strong scientific judgment, pharmacovigilance expertise, and the ability to communicate safety risks effectively across global teams.

GSK

Hybrid Permanent

Director, AI/ML MIDD Oncology Clinical Pharmacology, Modeling and Simulation

Lead and execute model-informed drug development strategies in oncology, applying advanced pharmacometric and AI/ML techniques to optimize clinical trial design, dose selection, and regulatory submissions. Drive innovation in quantitative clinical pharmacology across the R&D pipeline, from early development through lifecycle management, within a multidisciplinary translational medicine team.

GSK £119,250 – £198,750 pa

Director, AI/ML MIDD Oncology Clinical Pharmacology, Modeling and Simulation

Lead and deliver model-informed drug development (MIDD) strategies in oncology, applying advanced pharmacometric and AI/ML techniques to optimize clinical trial design, dose selection, and regulatory submissions. Work across multidisciplinary teams to advance GSK’s oncology pipeline using quantitative approaches including exposure-response modeling, disease progression models, and simulation-based trial design. Drive innovation through external collaborations, publications, and adoption of cutting-edge methodologies in clinical pharmacology.

GSK

Director, AI/ML MIDD Oncology Clinical Pharmacology, Modeling and Simulation

Lead and execute model-based drug development strategies in oncology, applying advanced pharmacometric and AI/ML techniques to optimize dose selection, trial design, and regulatory submissions. Drive innovation in clinical pharmacology through cross-functional collaboration and external engagement. Operate in a science-driven environment focused on accelerating the development of novel cancer therapies.

GSK US$188,100 – US$313,500 pa

Director, AI/ML MIDD Oncology Clinical Pharmacology, Modeling and Simulation

Lead clinical pharmacology and modelling & simulation efforts for oncology drug development, applying AI/ML and quantitative methods to optimise dosing, trial design, and regulatory strategy. Drive innovation in model-informed drug development across small molecules, biologics, and antibody-drug conjugates. Collaborate with cross-functional teams to accelerate therapies to patients using advanced pharmacometric and machine learning techniques.

GSK £188,100 – £313,500 pa