Latest regulatory affairs Jobs

Clinical Development Senior Medical Director - Vascular

Leads clinical development for vascular programmes across early and late phases, shaping study designs and clinical development plans. Works cross-functionally with translational science, regulatory, and commercial teams to advance medicines for vascular disease, with a focus on patient impact and scientific innovation. Provides medical oversight, contributes to regulatory submissions, and guides decision-making in a matrix environment.

GSK Stevenage, United Kingdom

Senior Medical Director, Oncology Clinical Development - Lung

This role involves leading clinical development in oncology, with a focus on lung cancer, providing medical oversight across study design, execution, and data interpretation. The Senior Medical Director will guide safety monitoring, contribute to regulatory interactions, and mentor junior medical staff within a global matrix team. The position emphasizes strategic input, external scientific engagement, and integration of clinical insights to advance therapies for high unmet need.

GSK Switzerland

Hybrid Permanent

Audit Lead

Lead GMP/GDP audit strategy and execution for a key technology area such as sterile biologics or medical devices across Pfizer’s global manufacturing and supply network. Conduct complex audits at internal sites and external partners, assess compliance with global regulations, coach auditors, and drive continuous improvement in quality systems. Work cross-functionally to align audit practices with emerging regulatory trends and support inspection readiness.

Pfizer London, SW7 2AP, United Kingdom US$162,900 – US$271,500 pa

On-site Permanent

Audit Lead

Lead GMP/GDP audit strategy and execution for a key technology area such as sterile biologics or medical devices within Pfizer’s global manufacturing and supply network. Conduct complex audits at Pfizer sites and external partners, ensuring compliance with global regulations and driving continuous improvement in quality systems. Provide expert coaching to auditors and collaborate across functions to address risks and enhance audit practices.

Pfizer US$162,900 – US$271,500 pa

On-site Permanent

Scientist, Clinical Biomarker Laboratory, Immuno-Assays - Cell Based

This role involves leading the development, qualification, and execution of complex cell-based immunoassays to support Moderna’s clinical trials across multiple therapeutic areas. The scientist will generate high-quality, reproducible data in compliance with GCP and GLP standards, while serving as a subject matter expert and collaborating with cross-functional teams. Emphasis is placed on innovation, scientific rigor, and advancing mRNA-based medicine through robust assay design and data analysis.

Moderna Oxford, United Kingdom

Hybrid Permanent

Senior Automation Engineer, Laboratory Automation & Biobanking

Design and optimize automated workflows for clinical biomarker testing and sample management using advanced liquid handling platforms and integrated data systems. Lead automation integration, troubleshooting, and digital connectivity across laboratory operations, ensuring compliance and scalability. Support AI-enabled workflows and mentorship within a regulated, innovation-driven environment.

Moderna Oxford, United Kingdom

Hybrid Permanent

Medical Safety Lead - CRM

The role involves monitoring clinical safety data, conducting medical assessments of adverse events, and identifying safety signals using both individual and aggregate data. The Medical Safety Lead will apply AI-enabled tools to enhance pharmacovigilance processes and provide critical medical input into regulatory submissions and safety documentation. Collaboration with global cross-functional teams is central to integrating safety insights across drug development programs.

Novartis London, United Kingdom £67,900 – £126,100 pa

GCP Excellence Monitoring Lead

This role leads the implementation of data-driven, adaptive monitoring strategies across global clinical trials to enhance trial quality and efficiency. The position shapes monitoring standards, tools, and governance frameworks while driving innovation through analytics and technology. It involves leading change initiatives and collaborating with cross-functional teams to improve clinical trial oversight at scale.

Novartis London, United Kingdom £67,900 – £126,100 pa

Safety Scientist – SERM (Safety Evaluation and Risk Management)

A Safety Scientist in GSK's Safety Evaluation and Risk Management (SERM) team is responsible for evaluating safety signals, contributing to risk management plans, and ensuring patient safety across clinical development and post-marketing phases. The role involves analyzing safety data from multiple sources, authoring regulatory reports, and collaborating with cross-functional teams to identify and mitigate risks. It requires strong scientific and medical expertise in pharmacovigilance within a global regulatory environment.

GSK PLN 215,250 – PLN 358,750 pa

Director, Control Domain Owner

Lead the strategy and governance of the Control data domain to enable structured regulatory submissions and digital specifications across GSK's global operations. Define standards for specifications, analytical procedures, and control strategies while aligning cross-functional teams in R&D, Quality, Manufacturing, and Regulatory. Drive data harmonisation and digital transformation initiatives to support future-ready, compliant data products.

GSK United Kingdom €115,500 – €192,500 pa

Hybrid Contract

Director, Control Domain Owner

Lead the strategy and governance of the Control data domain for structured regulatory submissions, defining standards for specifications, analytical methods, and control strategies across R&D, Quality, Manufacturing, and Regulatory. Partner with technology and data stewardship teams to deliver digital specifications and future data capabilities, ensuring compliance with evolving regulations like ICH M16.

GSK €115,500 – €192,500 pa

Director, Control Domain Owner

Lead the definition and governance of the Control data domain to enable structured regulatory submissions and digital specifications. Define standards for specifications, analytical procedures, and control strategies across R&D, Quality, Manufacturing, and Regulatory. Partner with data stewards and technology teams to build scalable, high-quality data products and ensure compliance with evolving regulatory requirements.

GSK

SERM Scientific Director

A senior scientific leadership role focused on pharmacovigilance and safety risk management for GSK's global pharmaceutical assets. The role involves leading safety strategy, evaluating clinical data, and ensuring regulatory compliance across development and post-marketing stages. It requires deep expertise in drug safety, cross-functional leadership, and communication with regulatory authorities.

GSK PLN 419,250 – PLN 698,750 pa

SPQS Data Steward

The role involves leading the implementation of data stewardship frameworks for Structured Product Quality Submissions (SPQS), ensuring high-quality, governed data across regulatory and manufacturing domains. The individual will establish metadata standards, controlled vocabularies, and data quality controls while working across R&D, Supply Chain, and Regulatory functions. This position supports GSK’s digital transformation by embedding data governance into business processes and regulatory submissions.

GSK United Kingdom €83,250 – €138,750 pa

SPQS Data Steward

This role involves leading the implementation of data stewardship frameworks for Structured Product Quality Submissions (SPQS) within a regulated pharmaceutical environment. The individual will establish metadata standards, controlled vocabularies, and data quality controls across R&D, supply chain, regulatory, and quality functions. They will coordinate cross-functional data governance, ensure compliance, and support digital transformation through structured regulatory submissions.

GSK €83,250 – €138,750 pa