Latest regulatory affairs Jobs

Clinical Development Medical Director- Hepatology

Lead clinical development strategy and execution for hepatology programs, designing and overseeing translational and clinical studies to advance novel liver disease treatments. Provide medical leadership across cross-functional teams, contribute to regulatory interactions, and drive innovation in drug development. Focus on identifying high-impact targets and delivering differentiated medicines with strong scientific and clinical foundations.

GSK £202,500 – £371,250 pa

Hybrid Permanent

Clinical Development Medical Director- Hepatology

Lead clinical development for hepatology assets within GSK’s Respiratory, Immunology & Inflammation Research Unit, driving translational research and early-phase clinical trials to validate novel liver disease targets. Provide medical oversight, design clinical development plans, and collaborate cross-functionally to advance innovative therapies from discovery through development. Work in a hybrid model with significant scientific leadership and regulatory engagement responsibilities.

GSK

Senior Research Associate, Bioanalytical & Molecular Assays

This role involves developing, optimizing, and validating molecular bioanalytical assays—such as qPCR, ddPCR, and RNA isolation—to support mRNA-based clinical programs. The scientist will work within GCL0-compliant (GCLP) frameworks to generate pharmacokinetic and pharmacodynamic data, ensuring regulatory compliance and data integrity. Collaboration with cross-functional teams and adoption of digital tools and automation are key to advancing clinical trial execution and analytical processes.

Moderna

Hybrid Permanent

Senior Project Specialist, Clinical Supplies

This role involves managing end-to-end clinical supply operations for Moderna’s mRNA-based therapeutic trials, including coordination of labeling, packaging, distribution, and temperature-controlled logistics. The specialist ensures investigational products are delivered on time and compliantly to clinical sites, supports IRT system testing, monitors vendor performance, and drives digital innovation and process improvements in supply chain execution.

Moderna

Hybrid Permanent

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

Lead the development and execution of global health economics and outcomes research (HEOR) strategies for Pfizer’s early-stage obesity and internal medicine pipeline. Design real-world evidence studies, economic models, and patient-reported outcomes frameworks to support market access and reimbursement. Collaborate with cross-functional teams and external stakeholders to generate data that demonstrates product value to payers and regulators.

Pfizer US$176,600 – US$294,300 pa

Statistics Leader / Associate Director of Statistics

Lead statistical strategy across oncology clinical development, from early-phase trials to regulatory submissions, using innovative methods like Bayesian modeling and real-world data integration. Collaborate with cross-functional teams to design studies, analyze data, and communicate insights to non-technical stakeholders. Drive methodological innovation while ensuring statistical rigor in a matrixed, global environment.

GSK £150,150 – £250,250 pa

Statistics Leader / Associate Director of Statistics

Lead statistical strategy across oncology clinical development, from early-phase trials to registration, using innovative methods like Bayesian modelling and real-world data. Design studies, guide regulatory submissions, and influence asset strategy within a matrix environment. Work closely with cross-functional teams to deliver robust statistical insights for key decision-making.

GSK £326,250 – £543,750 pa

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 design and analyze studies using advanced methods like Bayesian statistics, simulations, and real-world data, while collaborating with cross-functional teams. They will also drive innovation in statistical strategy and contribute to regulatory documentation and asset development.

GSK PLN 326,250 – PLN 543,750 pa

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

This role involves designing and executing bioanalytical and immunogenicity strategies to support mRNA-based clinical development programmes. The scientist will lead assay development—including ADA, nAb, PK, and PD assays—using platforms like ELISA, MSD, and cell culture, while ensuring regulatory compliance and contributing to Moderna's expanding capabilities in Harwell. The position emphasizes collaboration across multidisciplinary teams and integration of digital and AI-enabled tools to enhance data interpretation and decision-making.

Moderna

On-site

VP, Medicine Development Leader - Specialty Product Development

This role leads the global development of a medicine from clinical proof of concept to first-market approval, serving as the single point of accountability within GSK's matrixed R&D environment. The VP Medicine Development Leader will build and lead a cross-functional team, define strategic development plans, and ensure alignment with regulatory, commercial, and manufacturing stakeholders. The position emphasizes evidence-based decision-making, lifecycle planning, and patient-focused development across multiple indications.

GSK Stevenage, United Kingdom £242,250 – £403,750 pa

Director, Description Domain Owner

Lead the strategy and governance of the Description data domain for structured regulatory submissions, aligning product, material, and CMC data across R&D, Supply Chain, Regulatory, and Quality. Define standards, business requirements, and data products to support SPQS, IDMP, and digital regulatory capabilities, working closely with technology teams on SAP PLM and future system-of-record solutions.

GSK Barnard Castle, United Kingdom €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 safety reports, contributing to Risk Management Plans, and collaborating across global teams to ensure patient safety. The position supports governance activities and requires strong scientific, medical, and pharmacovigilance expertise.

GSK Irvine, Alba / Scotland, KA12 8EL, United Kingdom PLN 215,250 – PLN 358,750 pa

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 exposure-response analysis, population PK/PD, and quantitative systems pharmacology within a cross-functional R&D environment.

GSK Stevenage, United Kingdom £119,250 – £198,750 pa

Safety Scientist – SERM (Safety Evaluation and Risk Management)

This role involves leading safety evaluation and risk management for GSK’s global pharmaceutical products, both in clinical development and post-marketing settings. The Safety Scientist will conduct signal detection, contribute to Risk Management Plans, author safety reports, and collaborate across functions to ensure patient safety. The position requires scientific rigor, regulatory knowledge, and strong cross-functional leadership in a hybrid working environment.

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

Safety Scientist – SERM (Safety Evaluation and Risk Management)

This role involves leading safety evaluation and risk management activities for GSK’s global pharmaceutical products, both in clinical development and post-marketing settings. The scientist will conduct signal detection, author safety reports, contribute to risk management plans, and collaborate across functions to ensure patient safety. The position emphasizes scientific rigor, regulatory compliance, and cross-functional leadership within a global team environment.

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