Latest regulatory affairs Jobs

Senior Medical Director, Oncology Clinical Development - Lung

This role involves leading clinical development strategy for oncology, specifically lung cancer, providing medical oversight across trial design, safety monitoring, and data interpretation. The Senior Medical Director will guide cross-functional teams, engage with external experts, and contribute to regulatory submissions, ensuring patient-centred, scientifically rigorous development. Based in the UK with hybrid working, the position plays a key leadership role in advancing GSK’s oncology pipeline.

GSK Stevenage, United Kingdom PLN 593,250 – PLN 988,750 pa

Clinical Development Medical Director- Hepatology

Lead clinical development for hepatology assets, designing and executing translational and clinical studies to advance novel liver disease treatments. Provide medical oversight, shape development strategies, and collaborate across functions to deliver innovative medicines. Engage with regulators and external experts to drive proof-of-concept and lifecycle expansion opportunities.

GSK Stevenage, United Kingdom US$202,500 – US$371,250 pa

Hybrid Permanent

Global Development Lead, Internal Medicine, Sr. Director (non-MD)

This role leads clinical development for assigned assets in Internal Medicine within Pfizer's R&D division, serving as the primary clinical accountability point on the Global Medicine Team. The leader designs and executes global clinical development plans, guides cross-functional teams through trial phases, and supports regulatory submissions and lifecycle strategies. Emphasis is placed on innovation, patient engagement, and strategic external collaboration to advance obesity and internal medicine therapeutics.

Pfizer

On-site Permanent

Audit Lead

Lead and develop GMP/GDP audit strategy for sterile biologics, medical devices, or small molecule manufacturing, ensuring compliance with global regulations and Pfizer standards. Conduct complex audits across internal sites and external partners, coach auditors, and drive continuous improvement in quality systems. Collaborate with cross-functional teams to assess risks, resolve findings, and prepare for regulatory inspections.

Pfizer United States US$162,900 – US$271,500 pa

Remote Permanent

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

Senior Research Associate, Bioanalytical & Molecular Assays

This role involves developing, qualifying, and validating molecular bioanalytical assays—such as qPCR, ddPCR, and RT-qPCR—to support clinical pharmacokinetic and pharmacodynamic studies within a GCLp-compliant environment. The scientist will work closely with cross-functional teams to ensure robust data generation, maintain regulatory compliance, and integrate emerging digital and automation technologies into workflows. A strong focus on reagent management, assay documentation, and continuous process improvement is central to the position.

Moderna Oxford, United Kingdom

Hybrid Permanent

Senior Project Specialist, Clinical Supplies

This role involves coordinating clinical supply operations for Moderna’s mRNA-based therapeutics, ensuring investigational products are labeled, packaged, and distributed efficiently to clinical sites. The specialist will work cross-functionally with vendors and internal teams to maintain supply chain compliance, support IRT systems, manage temperature excursions, and drive digital innovation in supply operations.

Moderna Oxford, United Kingdom

Hybrid Permanent

Senior Specialist, Data Science & Artificial Intelligence

Design and deploy AI and automation solutions to accelerate clinical trial data workflows, building scalable tools for document processing and data extraction. Collaborate with scientific and technology teams to translate complex data challenges into practical engineering outcomes while ensuring compliance with regulatory standards in drug development. Work within a hybrid environment, championing AI adoption and innovation in healthcare.

Novartis London, United Kingdom £57,050 – £105,950 pa

Security Engineering Manager, London or Lausanne

As a Security Engineering Manager, you will lead and scale a high-performing team responsible for securing Isomorphic Labs' AI-driven drug discovery platform. You'll define the technical security roadmap across cloud infrastructure, IAM, secure SDLC, and security monitoring, while enabling rapid innovation for ML researchers and drug discovery teams. The role involves pioneering AI-first security architectures, leading transformational projects, and acting as a key liaison within the Alphabet/Google ecosystem.

Isomorphic Labs United Kingdom

Medical Director, Clinical Development (Oncology), Cambridge, MA

Leads clinical development strategy for oncology programs, translating AI-driven insights into actionable trial designs and serving as medical monitor. Collaborates with cross-functional teams to advance drug candidates from discovery through proof-of-concept, with responsibility for regulatory submissions and engagement with health authorities and key opinion leaders.

Isomorphic Labs England

Hybrid Permanent

(Senior) Group Leader, Advanced Genome Technologies - Plant Biology Institute

Lead a flagship research programme in advanced genome technologies and next-generation plant transformation, focusing on novel DNA/RNA delivery, plant regeneration, and high-throughput engineering. Build and manage an interdisciplinary team within a newly established, rapidly scaling plant sciences institute, driving scientific innovation from lab to real-world impact. Collaborate across AI, automation, and commercialisation teams to translate breakthroughs in plant biotechnology into scalable, sustainable solutions.

Ellison Institute of Technology Oxford, United Kingdom

On-site Permanent

SPQS Data Steward

Lead the implementation of data stewardship and governance frameworks for Structured Product Quality Submissions (SPQS) across global regulatory and manufacturing domains. Translate domain decisions into metadata standards, controlled vocabularies, and data quality controls while collaborating with R&D, Supply Chain, Regulatory, and Quality teams. Drive digital transformation by embedding data governance into business processes and digital solutions to support future regulatory submissions.

GSK €83,250 – €138,750 pa

Safety Scientist – SERM (Safety Evaluation and Risk Management)

This role involves leading safety evaluation and risk management activities for GSK’s pharmaceutical products, both in clinical development and post-marketing settings. The Safety Scientist will conduct signal detection, contribute to risk management plans, and author regulatory safety reports using diverse data sources. They will work cross-functionally to assess and communicate safety risks, ensuring patient safety is prioritized globally through scientifically rigorous analysis and proactive risk mitigation strategies.

GSK PLN 215,250 – PLN 358,750 pa