Latest regulatory affairs Jobs

Regulatory Affairs Manager, Oncology Therapeutic Group, Global Regulatory Affairs

Develop and execute global regulatory strategies for oncology assets, ensuring compliance and optimal labeling across regions. Collaborate with cross-functional teams to align regulatory plans with development goals and support submissions to health authorities. Focus on innovation, patient impact, and navigating complex regulatory landscapes in a hybrid working environment.

GSK €98,250 – €163,750 pa

Regulatory Affairs Manager, Oncology Therapeutic Group, Global Regulatory Affairs

Develop and execute global regulatory strategies for oncology assets, ensuring compliance and optimal product labeling across regions. Collaborate with cross-functional teams and regulatory authorities to support product development and approvals. Drive innovation and process improvements within the regulatory lifecycle.

GSK €98,250 – €163,750 pa

Manager, Oncology Regulatory Strategy

Lead regional regulatory strategy for oncology products across the Rest of World (ROW) region, aligning with global teams to ensure timely submissions, approvals, and commercially favorable labeling. Partner with project teams and health authorities to shape regulatory positions and influence the regional environment. Ensure compliance and effective implementation of regulatory standards throughout the product lifecycle.

Pfizer United Kingdom

PV Systems and Processes Lead x2

This role involves maintaining and improving CSL's global pharmacovigilance (PV) system, ensuring compliance with GVP and regulatory requirements. Responsibilities include leading investigations, managing deviations, coordinating inspections, and providing PV training across various functions and affiliates.

CSL United Kingdom

On-site Permanent

Director, Clinical Pharmacology

Lead clinical pharmacology and pharmacometrics strategy across rare disease and oncology programs, designing studies and supporting regulatory submissions. Oversee modeling and simulation to inform dose selection and development decisions, working closely with cross-functional teams in a TechBio environment powered by AI-driven drug discovery. Serve as the primary expert in regulatory interactions related to clinical pharmacology.

Recursion London, United Kingdom £118,300 – £136,500 pa

Hybrid Permanent

Director, Clinical Pharmacology

Lead clinical pharmacology and pharmacometrics strategy for rare disease and oncology programs, designing studies and guiding regulatory submissions. Oversee modeling and simulation to inform dose selection and accelerate drug development. Collaborate across translational, clinical, and preclinical teams in a tech-driven biopharma environment.

Recursion United Kingdom US$212,900 – US$297,000 pa

Hybrid Permanent

Principal Scientist, Bioanalytical & Molecular Assays

Lead the development and validation of molecular assays including RT-qPCR, dPCR, and NGS for clinical biomarker programs across Moderna's therapeutic pipeline. Drive end-to-end assay lifecycle management, ensure regulatory compliance with GCLP standards, and collaborate with cross-functional teams to deliver high-quality genomic data. Mentor scientists and integrate advanced analytics and AI-enabled tools to accelerate discovery and translational research.

Moderna Oxford, United Kingdom

Hybrid Permanent

Principal Scientist, Bioanalytical & Molecular Assays

This role involves leading the development and validation of advanced molecular assays—including RT-qPCR, dPCR, and NGS-based methods—for clinical biomarker programs at Moderna. The scientist will drive end-to-end assay lifecycle management, ensure compliance with GCLP and regulatory standards, and collaborate across multidisciplinary teams to generate high-quality genomic data. A key focus is integrating genomics, bioinformatics, and clinical insights to support drug development and inform future pipeline strategies.

Moderna

Hybrid Permanent

Global Labelling Associate Director, Content (Established Products)

Leads the development and maintenance of global labelling strategies and core documents for established pharmaceutical products, ensuring scientific accuracy and regulatory compliance. Facilitates cross-functional alignment and contributes to responses to health authority queries. Works within a hybrid or remote model depending on location, supporting consistent labelling across global markets.

Novartis London, United Kingdom

Hybrid Permanent

Global Labelling Associate Director, Content (Oncology)

This role involves developing and maintaining global labelling strategies and core documentation for oncology products across their lifecycle. The individual will lead cross-functional alignment on labelling content, interpret clinical data, and ensure compliance with global regulatory standards. They will also support health authority interactions and contribute to strategic planning and risk mitigation.

Novartis London, United Kingdom

Hybrid Permanent

Medical Devices Consultant - Senior Mechanical Engineer

Medical Devices Consultant - Senior Mechanical Engineer - CambridgeDue to the growth of a leading Medical Devices organisation, we are currently seeking a Senior Mechanical Engineer, Project Manager, Medical Devices Inventor, or Mechanical Design Consultant for a newly approved role....

Newton Colmore Cambridge, United Kingdom

Director of Nonclinical Safety, Cambridge, MA

Lead the development and execution of nonclinical safety strategies for small molecule drug candidates in oncology and non-oncology programs, integrating AI-driven predictive models with traditional toxicology. Build and scale the nonclinical safety function within an AI-first drug discovery environment, ensuring high-quality data feedback to refine computational models. Collaborate across preclinical, clinical, and regulatory teams to advance compounds through IND and NDA/MAA-enabling studies.

Isomorphic Labs Cambridge, United Kingdom

Director, Biostatistics

This role involves leading statistical strategy for gene therapy clinical development programs, with responsibilities spanning study design, regulatory engagement, and analysis oversight. The Director will ensure scientific and regulatory rigor in clinical trials, manage vendor performance, and contribute to submissions and publications. It is a hands-on leadership position within a cross-functional team environment.

Orchard Therapeutics London, United Kingdom

Hybrid Permanent

Associate Director, Clinical Trial Disclosure & Transparency

This role leads global clinical trial disclosure and transparency strategy, ensuring compliance with international regulations such as FDAAA 801, EU CTR, and MHRA requirements. The individual oversees study registration, results reporting, and layperson summaries, while managing redaction of confidential information for public release. They act as a key liaison with regulatory bodies and internal teams, driving process efficiency and vendor performance across the clinical development lifecycle.

CSL

Senior Manager, Medical Communications

This role involves leading medical communications, publications, and medical information activities for gene therapy programs at Orchard Therapeutics. The Senior Manager will translate complex scientific data into clear, compliant materials for healthcare professionals, oversee global publication planning, manage third-party agencies, and ensure accurate responses to medical inquiries. The position requires close collaboration with cross-functional teams and external experts to support clinical programs and disseminate research.

Orchard Therapeutics London, United Kingdom

Hybrid Permanent