Latest regulatory affairs Jobs

Director, Translational Science Lead

Leads translational science strategy for renal, inflammation, fibrosis, and neurodegeneration programs, driving biomarker development and validation from preclinical to clinical stages. Focuses on integrating multi-omics data, human assays, and novel technologies to inform clinical decision-making and patient stratification. Works across discovery and development to advance differentiated therapeutics through cross-functional collaboration and external partnerships.

GSK Canterbury, United Kingdom £178,200 – £297,000 pa

Hybrid Permanent

Medical Lead - Respiratory

This role involves leading the medical strategy for GSK's specialty respiratory portfolio, ensuring patient needs are at the forefront. Responsibilities include managing a medical therapy team, developing strategic plans, and engaging with healthcare professionals and regulatory bodies.

GSK United Kingdom

Hybrid Permanent

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

The Global Development Lead (GDL) is responsible for leading the clinical development of assigned assets in Internal Medicine. This involves designing and executing clinical trials, creating development plans, and collaborating with cross-functional teams to ensure regulatory approvals and strategic insights.

Pfizer

On-site Permanent

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

The Global Development Lead (GDL) is responsible for leading the clinical development of assigned assets in Internal Medicine. This role involves designing, executing, and interpreting clinical studies, creating development plans, and collaborating with cross-functional teams to ensure regulatory submissions and product approvals globally. The GDL also provides expert input on trial design, regulatory activities, and external stakeholder engagement.

Pfizer

On-site Permanent

Principal Statistical Programmer

The Principal Statistical Programmer leads statistical programming activities for large or pivotal clinical studies, ensuring high-quality and timely deliverables. They collaborate with cross-functional teams, mentor other programmers, and maintain compliance with industry standards.

Novartis London, United Kingdom

On-site Permanent

Assoc Director, Statistical Programming

The Associate Director, Statistical Programming, leads all statistical programming aspects for one or more drug development programs, ensuring cross-functional collaboration, resource allocation, and regulatory compliance. They coordinate activities, mentor programmers, and represent the team in audits and Health Authority meetings.

Novartis London, United Kingdom

Hybrid Permanent

Disease Area Lead - Hepatology, Renal and Cardiovascular diseases

Leads clinical operations strategy and delivery for GSK's Hepatology, Renal, and Cardiovascular disease portfolio, overseeing end-to-end development from early phase through phase IV. Responsible for shaping operational direction, managing cross-functional teams, driving data-led decision-making, and ensuring alignment with enterprise goals. Focuses on innovation, risk management, and talent development within a global R&D environment.

GSK US$242,550 – US$404,250 pa

On-site Permanent

Statistics Director, Oncology

This role involves leading statistical strategies for key oncology programs, designing robust clinical trials, and providing technical leadership to statisticians and statistical programmers. The position emphasizes innovation, regulatory interactions, and cross-functional collaboration to drive the development of new cancer therapies.

GSK United Kingdom

On-site Permanent

Statistics Director, Oncology

This role involves leading statistical strategies for oncology programs, designing clinical trials, and mentoring statisticians. The position emphasizes innovation, regulatory interactions, and cross-functional collaboration to advance new cancer therapies.

GSK

On-site Permanent

Clinical Programmer/Analyst

The Clinical Programmer/Analyst designs, builds, and reviews programming solutions to transform clinical and real-world data into reliable results for analysis and reporting. Working closely with statisticians and cross-functional teams, the role involves developing validated datasets, tables, listings, and figures in compliance with regulatory standards such as SDTM, ADaM, and TFL. The position supports agile delivery within a hybrid work environment and emphasizes code quality, regulatory adherence, and innovation in data programming practices.

GSK United Kingdom

Hybrid Permanent

NIS P&D Study Delivery Lead, Associate Director

The NIS P&D Study Delivery Lead, Associate Director, is responsible for leading the full lifecycle of clinical studies and trials within the Non-Interventional Study (NIS) portfolio. This includes designing, executing, and reporting complex regulatory commitment studies, managing team members, and ensuring compliance with regulatory guidelines. The role also involves leading operational decision-making, risk management, and driving innovation in study delivery through new technologies.

GSK £87,000 pa

Permanent

Principal Medical Writer

The Principal Medical Writer will lead the creation of high-quality clinical and regulatory documents, working closely with cross-functional teams to ensure scientific rigor and clear communication. This role involves strategic planning, project management, and translating complex data into clear narratives, with a focus on regulatory compliance and process improvement.

GSK United States

On-site Permanent

Principal Medical Writer

The Principal Medical Writer will lead the creation of high-quality clinical and regulatory documents, working closely with cross-functional teams to ensure scientific rigor and compliance. This role involves strategic planning, project management, and translating complex data into clear narratives, with a focus on regulatory submissions and process improvements.

GSK

On-site Permanent

Principal Programmer / Analyst

This role involves leading programming activities for complex clinical studies, ensuring high-quality and timely outputs. You will collaborate with cross-functional teams, mentor junior programmers, and support regulatory interactions, while fostering quality assurance and innovation.

GSK

Hybrid Permanent

Therapy Supply Chain Manager

Leads end-to-end supply planning and execution for a designated therapy area, ensuring uninterrupted patient access to medicines. Works cross-functionally across planning, manufacturing, quality, and commercial teams to resolve supply disruptions, drive inventory optimisation, and implement continuous improvement initiatives using data analysis and planning systems. Focuses on risk mitigation, regulatory compliance, and performance monitoring within a global pharmaceutical supply chain.

GSK United Kingdom

Hybrid Temporary