Latest regulatory affairs Jobs

Executive Medical Director, Clinical Development Lead - Oncology GU

This role involves leading the clinical development of oncology drugs, specifically in genitourinary cancers. Responsibilities include defining clinical strategies, leading governance discussions, and representing the asset in external engagements. The role emphasizes data-driven decision-making and leveraging advanced analytics to enhance development speed and precision.

GSK Canterbury, United Kingdom

Executive Medical Director, Clinical Development Lead - Oncology GU

This role involves leading the clinical development of oncology GU (genitourinary) treatments at GSK, defining the clinical strategy, and serving as the clinical authority for the asset. Responsibilities include strategic planning, governance, and external engagement with health authorities and advisory boards.

GSK Stevenage, United Kingdom

Principal Engineer, Drug Product

The Principal Engineer, Drug Product will lead the development of global engineering standards for sterile 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

(Fixed-Term) Manufacturing Associate

This role involves hands-on mRNA vaccine production operations at Moderna’s Harwell facility, adhering to cGMP standards and collaborating with Quality Assurance. Responsibilities include operating production equipment, maintaining compliance, troubleshooting, and contributing to continuous improvement and digital innovation.

Moderna Oxford, United Kingdom

Innovation Capability Director - Global Clinical Operations (GCO)

This role involves leading the identification, implementation, and scaling of innovative patient recruitment solutions for clinical trials. The director will work with global teams and technology partners to improve clinical trial participation, focusing on digital marketing and AI-driven approaches.

Novartis London, United Kingdom

Director, Translational Medicine Expert (Neurodegeneration)

This role involves leading the translational strategy for neurodegenerative programs, from preclinical research to early clinical development. Responsibilities include biomarker strategy, clinical trial design, and cross-functional leadership, with a focus on integrating patient-centered approaches and advancing scientific collaborations.

Novartis London, United Kingdom

Controlled Environment Lead - Plant Biology Institute

The Controlled Environment Lead will build and oversee plant growth and phenotyping facilities, ensuring controlled and reproducible environments for high-impact plant science research. Responsibilities include hands-on cultivation, data collection, and leading the team to support scientific and commercial goals.

Ellison Institute of Technology Oxford, United Kingdom

On-site Permanent

Senior Group Leader, Industry - Plant Biology Institute

The Senior Group Leader, Industry will lead a transformative research programme in plant biotechnology, focusing on advancing fundamental and applied science in photosynthesis, carbon assimilation, and nitrogen fixation. They will build and manage a high-performing interdisciplinary team, develop cross-sector collaborations, and ensure research excellence is translated into commercial opportunities.

Ellison Institute of Technology Oxford, United Kingdom

On-site Permanent

Data Solution Architect

The Data Solution Architect designs end-to-end data solutions, including data integration, warehousing, governance, and analytics. They work closely with technical leads and data teams to ensure scalable, secure, and governed solutions, influencing the data architecture of a rapidly evolving biotech company.

Autolus United Kingdom

Senior Engineer, CSV Validation

This role involves end-to-end ownership of computerised system validation (CSV) for GxP-regulated systems used in the manufacturing and testing of advanced CAR-T cell therapies. The engineer will author and execute validation documentation, ensure compliance with international regulations (e.g. FDA 21 CFR Part 11, EU GMP Annex 11), manage change controls and CAPAs, and support regulatory inspections. The position requires strong technical writing, cross-functional collaboration, and expertise in GAMP 5 and data integrity within a biopharmaceutical context.

Autolus Stevenage, United Kingdom

Research Director

This role involves leading and developing high-performing scientific and operational teams, defining and delivering strategic objectives, driving innovation through emerging technologies, and ensuring compliance with industry regulations. The position also includes managing departmental budgets, contributing to business planning, and building strong relationships with external stakeholders.

Reed Cv47Ez, United Kingdom