Latest regulatory affairs Jobs

Senior Medical Director, Oncology Clinical Development - GU

Leads clinical development for oncology assets, focusing on genitourinary (GU) cancers. Responsible for designing and executing phase 1-3 trials, ensuring scientific integrity, regulatory compliance, and collaboration with internal and external experts. Works within a global matrix to advance GSK’s innovative oncology pipeline from development through market launch.

GSK US$284,250 – US$473,750 pa

Hybrid Permanent

Senior Medical Director, Oncology Clinical Development - GU

Leads clinical development for oncology assets, focusing on genitourinary (GU) cancers, with responsibility for designing and executing global Phase 1-3 trials. Provides medical oversight, ensures scientific integrity, and collaborates with internal teams and external experts to support regulatory submissions and product lifecycle management. Engages in strategic initiatives and represents GSK in medical forums.

GSK United Kingdom US$284,250 – US$473,750 pa

Hybrid Permanent

Regional Head, Pharmacovigilance Quality (PVQA)

This role involves providing end-to-end quality assurance and vigilance expertise for global and local pharmacovigilance activities. Responsibilities include driving regional quality oversight, ensuring compliance with regulations, and leading quality improvement initiatives.

Novartis London, United Kingdom £63,917 – £118,703 pa

Principal Scientist, Bioanalytical & Molecular Assays

Lead the development and validation of molecular assays including RT-qPCR, dPCR, and NGS for clinical biomarker programs across Moderna's therapeutic pipeline. Drive end-to-end assay lifecycle management, ensure regulatory compliance with GCLP standards, and collaborate with cross-functional teams to deliver high-quality genomic data. Mentor scientists and integrate advanced analytics and AI-enabled tools to accelerate discovery and translational research.

Moderna Oxford, United Kingdom

Hybrid Permanent

Principal Scientist, Bioanalytical & Molecular Assays

This role involves leading the development and validation of advanced molecular assays—including RT-qPCR, dPCR, and NGS-based methods—for clinical biomarker programs at Moderna. The scientist will drive end-to-end assay lifecycle management, ensure compliance with GCLP and regulatory standards, and collaborate across multidisciplinary teams to generate high-quality genomic data. A key focus is integrating genomics, bioinformatics, and clinical insights to support drug development and inform future pipeline strategies.

Moderna

Hybrid Permanent

Associate Director / Director, Biostatistics

This role involves providing strategic statistical leadership for Health Technology Assessment, pricing, and reimbursement activities. The candidate will work with cross-functional teams to ensure HTA evidence is scientifically rigorous and aligned with payer requirements. Responsibilities include implementing HTA methods, contributing to evidence synthesis, and mentoring biostatisticians.

Novartis London, United Kingdom

Principal Software Engineer

This role involves providing technical leadership for software development in a medical wearable technology company, with responsibility for evolving the software architecture and ensuring compliance with IEC 62304 standards. The engineer will work across software, firmware, and signal processing domains, supporting regulatory approval and commercial launch. It is a hands-on position requiring deep expertise in regulated medical device software and systems-level engineering.

Cure Talent Hathern, Leicestershire, LE12 5LA, United Kingdom £70,000 – £85,000 pa

Preclinical In-Vitro Toxicology Scientist

This role involves leading in-vitro toxicology studies within a regulated preclinical environment, focusing on assay development and execution for product safety assessment. The scientist will apply advanced cell-based methods including Neutral Red, Ames, and micronucleus assays, interpret complex biological data, and support regulatory submissions. Collaboration with internal teams and external partners is key, alongside method validation and scientific reporting in a quality-assured laboratory setting.

Hudson Shribman United Kingdom £55,000 – £70,000 pa

Senior Clinical Trial Case Manager

This role involves leading safety data review and pharmacovigilance activities within clinical trials, ensuring compliance with international regulations such as GxP. The individual will mentor team members, manage CAPAs, support regulatory inspections, and contribute to safety reporting and risk management. Key responsibilities include MedDRA coding, safety data analysis, and developing pharmacovigilance procedures to support global regulatory requirements.

CSL

On-site Permanent

Global Safety Lead - Formulation Safety

Leads global safety strategy for formulation safety across the product lifecycle, focusing on clinical safety evaluation, signal detection, and risk management. Oversees production of key pharmacovigilance documents and ensures compliance with regulatory standards. Acts as safety representative in cross-functional teams and drives safety specifications and risk mitigation plans.

CSL

Clinical Data & Systems Lead

This role involves leading complex clinical technology transformation and data migration initiatives across the clinical trial ecosystem. Responsibilities include managing end-to-end migration programmes, data validation, and ensuring compliance with regulatory requirements. The role also involves collaborating with global stakeholders to deliver scalable and compliant technology solutions.

HAYS Specialist Recruitment Cambridge, United Kingdom £80,000 – £120,000 pa

Hybrid Permanent

Research Associate in Functional Genomics

This role involves establishing and running iPSC-derived kidney and ureteric bud organoid models, using CRISPR interference to perturb candidate cis-regulatory elements, and profiling the consequences using advanced techniques like single-nucleus multiomics and CUT&RUN. You will work collaboratively with bioinformaticians and clinicians to generate and test hypotheses, and have opportunities for advanced training and independent research.

Imperial College London London, United Kingdom £50 – £59 pa

Contract

Senior Manager, PV Operations

This role leads global pharmacovigilance operations for a gene therapy company, overseeing safety case management, regulatory reporting, and compliance across clinical and post-marketing portfolios. The individual ensures robust, scalable processes and systems, including vendor oversight, safety database administration, and audit readiness. They play a key technical and operational role in SOP development, inspection preparedness, and cross-functional collaboration to support signal detection and risk management.

Orchard Therapeutics London, United Kingdom

Hybrid Permanent

Director - Immunoassay Development

Lead the development and optimisation of quantitative immunoassays for at-home diagnostic tests, from initial design through validation and commercialisation. This hands-on leadership role involves managing scientific collaborators, ensuring regulatory compliance, and translating lab-based assays into point-of-care formats such as lateral flow and microfluidic cartridges. Work with human biological samples and drive assay performance in sensitivity, precision, and stability.

Talentmark Stevenage, Hertfordshire, United Kingdom £75,000 – £100,000 pa

Medical Devices Project Leader - Warwick

Lead the development of medical devices from concept to commercial launch within a multidisciplinary engineering team. Provide technical leadership, mentor junior engineers, and ensure robust design and compliance, particularly for products involving injection-moulded plastic components. Contribute to regulatory strategy and full lifecycle development in a fast-paced environment focused on improving patient outcomes.

Newton Colmore Warwick, United Kingdom

On-site Permanent