Latest regulatory affairs Jobs

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Senior Medical Director, Oncology Clinical Development - GU

The Senior Medical Director, Oncology Clinical Development - GU will lead clinical research activities for GSK’s oncology portfolio, focusing on GU cancers. Responsibilities include developing and executing clinical trials, collaborating with internal and external experts, and ensuring regulatory compliance. The role requires significant experience in GU oncology drug development and a strong medical background.

GSK
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Vice President - Oncology Clinical Development, Disease Area Head- Hematology

This role involves leading the clinical development strategy for GSK's Hematology portfolio, from early-phase studies to market launch. Responsibilities include shaping scientific and clinical strategies, managing cross-functional teams, and ensuring regulatory compliance and market readiness for innovative oncology therapies.

GSK Stevenage, United Kingdom

Principal Scientist, Immunogenicity and Ligand Binding Assays

This role involves leading scientific strategy and execution for immunogenicity and ligand binding assays (LBA) in support of Moderna’s mRNA-LNP therapeutic programs. The Principal Scientist will oversee regulated bioanalytical activities including assay development, validation, and sample analysis, ensuring compliance with GcLP, GLP, and GCP standards. The position plays a key role in clinical development by generating high-quality data to inform regulatory submissions and advance innovative medicines, with opportunities to engage in AI-enabled and digital analytical approaches.

Moderna
Hybrid Permanent

Principal Engineer, Drug Product

The Principal Engineer, Drug Product will lead the development of global engineering standards for drug product processes, including filling, inspection, packaging, and labeling. They will manage capital projects, ensure regulatory compliance, and drive innovation in manufacturing technologies across Moderna’s global network.

Moderna United States £142,500 – £256,500 pa

Senior Principal Biostatistician

Lead statistical work across clinical trials, developing protocols, analysis plans, and reporting while driving innovative trial designs and methodologies. Collaborate with cross-functional teams including clinical, regulatory, and programming to support data-driven decision-making in drug development. Engage with external stakeholders such as health authorities and scientific communities to advance quantitative sciences in a pharmaceutical context.

Novartis London, United Kingdom
Hybrid Permanent

Contracting Specialist - Clinical Study Start-Up

This role involves leading the contracting activities for clinical studies, negotiating agreements, and ensuring compliance with regulatory requirements. The Contracting Specialist will collaborate with various stakeholders to accelerate study activation and patient recruitment.

Novartis London, United Kingdom

Process / Equipment Engineer

The Process/Equipment Engineer provides technical support for the Bio-Vaccines Suites, ensuring equipment reliability and resolving manufacturing issues. Responsibilities include troubleshooting, leading investigations, validation, compliance, and continuous improvement initiatives.

Appcast Enterprise Dublin, Alba / Scotland, IV17 0YF, United Kingdom

Process Technician 11-Month

Operate and monitor manufacturing processes in a cGMP-regulated biopharmaceutical environment, supporting the production of life-changing medicines. Perform troubleshooting, contribute to process improvements using Lean methodologies, and assist in validation and documentation activities. Work within a rotating shift pattern in a safety-focused, highly regulated team setting.

Appcast Enterprise Dublin, Alba / Scotland, IV17 0YF, United Kingdom
Contract

Statistician

The Statistician will provide statistical expertise and support across R&D, clinical, product support, and marketing functions. Key responsibilities include designing and analyzing studies, developing product algorithms, and communicating statistical findings to both technical and non-technical audiences.

SPD Development Company Ltd Cardington, Bedfordshire, United Kingdom
Hybrid Contract

Life Sciences Operations and Technical Manager

This role involves managing the day-to-day operations of a life sciences facility, including laboratory and office space, ensuring compliance with health and safety standards, and supporting tenants. The manager will also handle leasing, facility maintenance, and technical services, contributing to the facility's growth and development.

SRG Aberdeen, Alba / Scotland, United Kingdom
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GLP/GCLP Vendor Oversight and QA Lead (EU)

This role focuses on end-to-end quality oversight of external vendors and suppliers involved in regulated R&D activities, ensuring compliance with GLP, GCP, GMP, and GVP standards. The individual will lead vendor qualification, audit management, quality agreement negotiation, and continuous performance monitoring, while collaborating with cross-functional teams including Clinical, CMC, Safety, and Legal. A key aspect is driving compliance, data integrity (ALCOA+), and continuous improvement across third-party partners through risk-based assessments, CAPA follow-up, and QMS integration.

CSL United Kingdom
On-site Permanent
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Bioanalytical Lead, London

Lead the development and execution of bioanalytical strategies for a diverse portfolio of AI-designed therapeutics, including small molecules, biologics, and ADCs. Design and validate PK, PD, and immunogenicity assays, manage global CROs, and integrate bioanalytical data into AI models to refine drug discovery. Play a key role in IND-enabling studies and cross-functional preclinical development in a hybrid London-based role.

Isomorphic Labs London, United Kingdom
Hybrid Permanent
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Director of Clinical Pharmacology, Cambridge, MA

Lead clinical pharmacology strategy for small molecule programs in oncology and non-oncology areas, designing and executing studies from Phase 1 through late development. Utilize AI-driven models for PK/PD prediction, dose optimization, and regulatory submissions, while managing CROs and translating preclinical data into human dosing strategies.

Isomorphic Labs Cambridge, United Kingdom

Scientist, Molecular Biology - Plant Biology Institute

This role involves designing and conducting molecular biology experiments within a plant science research programme focused on improving global food production and sustainability. The scientist will work on stage-gated research milestones, contribute to intellectual property and publications, and collaborate with cross-functional teams including AI, automation, and generative biology experts. Emphasis is placed on translating scientific discoveries into scalable, real-world commercial solutions with ethical and environmental considerations.

Ellison Institute of Technology Oxford, United Kingdom
On-site Permanent

Scientist, Advanced Genome Technologies - Plant Biology Institute

This role involves designing and conducting experiments in advanced genome technologies and next-generation plant transformation to enhance plant engineering capabilities. The scientist will work on genetic manipulation, DNA/RNA delivery, and plant regeneration, contributing to high-impact research with real-world applications in food security and sustainable agriculture. Collaboration with AI, automation, and generative biology experts across EIT’s ecosystem is a key part of the role.

Ellison Institute of Technology Oxford, United Kingdom
On-site Permanent