Latest regulatory affairs Jobs

Clinical Development Medical Director - Cardiovascular

This role involves leading clinical development for cardiovascular assets within GSK's Respiratory, Immunology & Inflammation Research Unit. The Medical Director will design and execute clinical development plans, provide medical oversight, and collaborate across functions to advance translational and clinical studies. The position emphasizes scientific leadership, regulatory engagement, and strategic input to bring innovative medicines to patients.

GSK

Hybrid Permanent

Associate Director of Clinical Sciences

Lead clinical sciences strategy and execution for global oncology studies, with responsibility for end-to-end protocol development, clinical data review, and cross-functional collaboration. Focus on immuno-oncology with strong emphasis on regulatory compliance, patient safety, and scientific leadership across clinical development phases. Work within a matrix environment to guide study design, interpretation, and regulatory submissions.

GSK Stevenage, United Kingdom

Precision Medicine Director

The role involves leading the development and execution of precision medicine strategies within global clinical programs, focusing on biomarker and diagnostic initiatives for patient selection and regulatory support. It requires close collaboration with cross-functional teams and external partners, ensuring compliance with medical device regulations and high-quality scientific delivery. The position is embedded in the Neuroscience disease area, emphasizing strategic input into clinical trial design and regulatory submissions.

Novartis London, United Kingdom

Hybrid Permanent

Precision Medicine Director

The Precision Medicine Director leads the development and execution of biomarker and diagnostic strategies within global clinical programs, focusing on patient selection and regulatory-aligned trial design. This role acts as a scientific expert, guiding cross-functional teams in neuroscience-focused initiatives and ensuring compliance with medical device regulations. The position emphasizes strategic leadership in precision medicine, with strong collaboration across clinical development, diagnostics, and external research partners.

Novartis Ardross, Alba / Scotland, IV17 0YF, United Kingdom

Hybrid Permanent

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

This role leads clinical development for Internal Medicine assets within Pfizer's Research & Development division, serving as the primary clinical accountability point for global regulatory submissions. The individual will direct cross-functional teams in designing and executing Phase 1-3 trials, develop clinical development plans, and contribute to regulatory filings, safety reports, and product labeling. The position emphasizes leadership in obesity-related therapeutics, digital innovation in clinical development, and engagement with external scientific and regulatory stakeholders.

Pfizer

On-site Permanent

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

This role involves leading clinical development for Internal Medicine assets within Pfizer's Research & Development division, with a focus on obesity and chronic weight management. The Global Development Lead is responsible for end-to-end clinical strategy, including designing and executing global clinical trials, regulatory submissions, and cross-functional team leadership. The position requires deep therapeutic expertise, strategic input into product development, and engagement with external stakeholders such as advisory boards and regulatory bodies.

Pfizer US$214,900 – US$358,100 pa

On-site Permanent

(Fixed Term) Manufacturing Associate I

Operate production equipment for mRNA vaccine manufacturing in compliance with cGMP and safety standards. Perform routine maintenance, support deviation investigations, and contribute to continuous improvement in a highly regulated, technology-driven environment. Work collaboratively with QA and cross-functional teams to ensure timely batch disposition and operational excellence.

Moderna

On-site Temporary

(Fixed-Term) Manufacturing Associate I

Operate and maintain equipment in a cGMP-compliant, highly automated mRNA vaccine production environment at Moderna's Oxford facility. Perform production operations, support quality assurance, troubleshoot issues, and contribute to continuous improvement initiatives using digital systems and advanced manufacturing technologies. Work within a 2-2-3 rotating shift pattern to ensure reliable, safe, and compliant vaccine manufacturing.

Moderna Oxford, United Kingdom

Senior Research Technician

This role involves leading core technical operations in lentiviral vector production and analytical testing within a gene therapy research environment. The Senior Research Technician will manage staff, oversee molecular biology workflows, ensure data integrity, and support translational research through robust laboratory practices and process improvements. Key responsibilities include vector design, production optimisation, assay development, and compliance with regulatory standards.

Orchard Therapeutics London, United Kingdom

On-site Permanent

Biomedical Scientist

This role involves supporting the installation, validation, and verification of new laboratory analysers within an NHS clinical chemistry setting. The Biomedical Scientist will ensure equipment meets performance standards, troubleshoot technical issues, and maintain compliance with quality and regulatory requirements. It offers hands-on involvement in a major laboratory transformation project within a modern NHS environment.

Acorn by Synergie Woolstone, Milton Keynes, Buckinghamshire, United Kingdom

On-site Temporary

Immunohistochemistry Scientist

Perform hands-on development and optimisation of automated immunohistochemistry (IHC) assays in a preclinical research environment. Independently design experiments, analyse data, and contribute to client projects requiring scientific rigour and regulatory compliance. Support study reporting, troubleshooting, and process improvement within a GLP/GxP-aligned laboratory setting.

RBW Consulting Royston, Hertfordshire, United Kingdom

On-site Permanent

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

Lab Manager

Main Purpose of Role:As Lab Manager, you will lead a critical operational function at Cogent Breeding, ensuring the delivery of high-quality laboratory services that support our customers, breeding programmes, and business objectives. You will be responsible for driving operational excellence,...

Cogent Bt364Rl, United Kingdom

Radiopharmaceutical QP

CMDO is Seeking to Appoint a Qualified Person. The Organisation is Engaged in Developing and Manufacturing New Medicines and Novel Formulations, Including a Wide Range of Oral Solid and Liquid Dosage Forms, Sterilised and Aseptically Filled Products, as well as...

CV-Library City of Westminster, Greater London

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