Latest regulatory affairs Jobs

Medical Director Clinical Development- Respiratory

Leads clinical development for respiratory programs within GSK’s R&D pipeline, driving translational and clinical strategies from early to late stages. Provides medical oversight, designs studies, and collaborates across functions to deliver innovative medicines addressing immune-mediated respiratory diseases. Engages with regulators, investigators, and internal teams to advance asset development and shape future treatment paradigms.

GSK London, United Kingdom

Hybrid Permanent

Medical Director Clinical Development- Respiratory

Lead clinical development for respiratory assets within GSK’s Respiratory, Immunology & Inflammation Research Unit, driving translational and clinical strategies from early to late stages. Provide medical oversight, design studies, and collaborate across functions to deliver innovative medicines addressing unmet patient needs in respiratory disease.

GSK Stevenage, United Kingdom

Global Medical Affairs Director, Immunology, Rap-cel (CAR-T)

Leads global medical strategy for a novel CAR-T therapy in autoimmune diseases, driving evidence generation and scientific engagement with key opinion leaders, patient groups, and research institutions. Oversees real-world evidence, registries, and investigator-initiated studies while ensuring compliance and medical governance. Collaborates cross-functionally to shape clinical development, regulatory, and launch strategies in a rapidly evolving immunology landscape.

Novartis London, United Kingdom £93,870 – £174,330 pa

Hybrid Permanent

Associate Director, Global Regulatory Science, CMC

This role leads global regulatory CMC strategy for mRNA-based medicines, developing and implementing regulatory plans for international submissions. The individual will guide CMC documentation, interact with health authorities, and provide strategic input across product development stages, ensuring compliance with EU and global regulations. The position plays a key part in advancing Moderna’s pipeline of transformative therapeutics across vaccines, oncology, and rare diseases.

Moderna

Hybrid Permanent

Associate Director, CMC Regulatory Science, International

This role involves leading CMC regulatory strategy for global mRNA product development, preparing and reviewing regulatory submissions, and guiding cross-functional teams on compliance and agency interactions. The position requires deep expertise in biologics CMC regulations, particularly in EU and ROW markets, and plays a key part in shaping regulatory pathways across vaccines, oncology, and rare diseases. Based at the Harwell site, it emphasizes in-office collaboration within a multidisciplinary team.

Moderna

On-site Permanent

(Senior) Clinical Development Medical Director

A Senior Clinical Development Medical Director will lead cardiovascular clinical programs, providing strategic medical input and ensuring regulatory and safety compliance. The role involves guiding clinical trial execution, collaborating with global teams, and translating scientific data into development pathways. Expertise in cardiovascular drug development and global regulatory processes is essential.

Novartis London, United Kingdom

Hybrid Permanent

Audit Lead

Lead and develop GMP/GDP audit strategy for a key technology area such as sterile biologics or medical devices, ensuring compliance with global regulations and emerging trends. Conduct complex audits across Pfizer facilities, contract manufacturers, and suppliers, while coaching auditors and driving continuous improvement in quality systems. Collaborate with cross-functional teams to assess risks, resolve findings, and prepare for regulatory inspections.

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

Remote Permanent

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

This role involves leading clinical development for Internal Medicine assets within Pfizer's Research & Development division, with end-to-end accountability for creating and executing global clinical development plans. The position requires deep therapeutic expertise in chronic weight management or endocrinology, leadership of cross-functional teams, and active engagement in trial design, regulatory submissions, and lifecycle strategy. The role operates in a hybrid work model and may include responsibilities across the Obesity portfolio.

Pfizer United States £274,500 – £457,500 pa

On-site Permanent

VP, Clinical Operations and Data Management

Leads the end-to-end delivery of global clinical trials from start-up to close-out, ensuring compliance, data integrity, and on-time execution. Oversees clinical operations and data management functions, including vendor and site management, database design, and regulatory coordination. Focuses on strategic planning, cross-functional collaboration, and team development within a regulatory-compliant environment.

Orchard Therapeutics London, United Kingdom

Hybrid

Senior / Staff Medical Firmware Engineer

Lead the design and development of safety-critical embedded firmware for next-generation insulin pump systems in a regulated medical device environment. Establish robust firmware lifecycle processes, ensure compliance with IEC 62304 and ISO 13485, and collaborate with cross-functional teams including Quality and Regulatory. Mentor engineers and shape technical direction while working on technology that directly improves patient outcomes.

Verso Recruitment Teversham, Cambridgeshire, United Kingdom

Senior Clinical Trial Case Manager

Manages clinical trial case management activities, ensuring compliance with international and national regulations including GxP and pharmacovigilance standards. Oversees safety reporting, vendor performance, and case processing for serious adverse events, while acting as a key liaison for inspections and audits. Provides training, supports database enhancements, and ensures accurate coding and consistency in safety data analysis.

CSL

Senior Scientist (In vivo Pharmacology & Translational Sciences), Cambridge, MA

Lead translational strategies for oncology and immunology programs by designing in vivo pharmacology and PK/PD studies to validate AI-designed drug candidates. Bridge computational predictions with experimental validation through CRO partnerships and biomarker-driven approaches. Drive preclinical data generation to inform clinical trial design and regulatory filings.

Isomorphic Labs England

Hybrid Permanent

Director, Search & Evaluation Early TA Lead (CVR and Haem)

Leads strategic sourcing and evaluation of early-stage innovation in Hematology and Cardiovascular/Renal therapeutic areas, identifying preclinical to Phase 1 assets. Drives external partnership strategies, coordinates cross-functional due diligence across scientific and clinical domains, and supports deal execution. Embedded within therapeutic leadership teams to align external opportunities with portfolio strategy.

CSL

On-site Permanent

Director, Translational Medicine, Oncology, Cambridge, MA

Lead the development and execution of translational medicine strategies for oncology programs, integrating AI-driven insights to inform clinical trial design and biomarker development. Collaborate with cross-functional teams to translate preclinical findings into clinical applications and advance companion diagnostics. Play a key role in shaping the scientific direction of early-stage drug development using cutting-edge methodologies and digital biology approaches.

Isomorphic Labs Cambridge, United Kingdom

QA Associate

The role involves supporting the quality assurance of autologous CAR T-cell therapies in a GMP-compliant environment, with responsibilities including batch record review, documentation control, label verification, and compliance risk identification. The position operates within a multi-product cell and gene therapy facility, contributing to batch release activities and inspection readiness across international markets. Work includes collaboration with internal teams and adherence to strict regulatory and safety standards.

Autolus Stevenage, United Kingdom

On-site Permanent