Latest regulatory affairs Jobs

Director, Oncology Clinical Biomarkers

This role involves developing and implementing biomarker strategies for late-stage oncology clinical trials, collaborating with cross-functional teams to identify patient populations and optimize drug development. The Director will leverage cutting-edge technologies and methodologies to validate biomarkers and inform clinical decisions.

GSK Stevenage, United Kingdom £189,750 – £316,250 pa

On-site Permanent

Director, Oncology Clinical Biomarkers

This role involves developing and implementing biomarker strategies to support the clinical development of late-stage oncology assets. Responsibilities include collaborating with cross-functional teams, validating biomarker strategies, and integrating them into clinical plans to optimize decision-making and patient stratification.

GSK United States £189,750 – £316,250 pa

On-site Permanent

Head of RII or Oncology Programming

This role involves leading the clinical data programming for GSK's Respiratory, Immunology & Inflammation or Oncology Research Unit. Responsibilities include setting high standards for data quality, driving innovation with technologies like Generative AI, and collaborating with cross-functional teams to accelerate the development and submission of medicines and vaccines.

GSK

On-site Permanent

Head of RII or Oncology Programming

This senior leadership role involves overseeing the transformation of clinical data into regulatory-ready evidence for GSK's Respiratory, Immunology & Inflammation, or Oncology Research Units. The Head of Programming will lead a global team, drive strategic initiatives, and champion innovation in clinical programming, ensuring high standards of quality and compliance.

GSK

On-site Permanent

Programming Leader

The Programming Leader will oversee project-level and study-level programming strategy and delivery for multiple complex studies in GSK's global pipeline. You will collaborate with cross-functional teams, ensure high-quality outputs, and champion agile methodologies and new technologies to enhance programming efficiency and data analysis.

GSK

Hybrid Permanent

SME - MSAT EM Technical Operations DS/DP

This role involves collaborating with internal and external stakeholders to support the commercial manufacture of large molecule drug substances and sterile drug products. Responsibilities include executing technical strategies, managing product lifecycle activities, and ensuring compliance with GMP standards. The role also involves supporting CMOs in audits, technical transfers, and continuous improvement initiatives.

GSK East Hertfordshire, United Kingdom

On-site Permanent

Senior SME - MSAT EM Tech Ops DS DP

This role involves collaborating with internal and external stakeholders to support the commercial manufacture of large molecule drug substances and sterile drug products. Responsibilities include executing technical strategies, providing lifecycle support, and ensuring compliance with GMP standards. The role also focuses on continuous improvement and managing technical transfers between contract manufacturing organizations (CMOs).

GSK East Hertfordshire, United Kingdom

On-site Permanent

SME - MSAT EM Technical Operations DS/DP

This role involves collaborating with internal and external stakeholders to support the commercial manufacture of large molecule drug substances and sterile drug products. Responsibilities include executing technical strategies, managing product lifecycle activities, and ensuring compliance with GMP standards. The position also involves supporting CMOs in audits, technical transfers, and continuous improvement initiatives.

GSK United States

On-site Permanent

SME - MSAT EM Technical Operations DS/DP

This role involves collaborating with internal and external stakeholders to support the commercial manufacture of large molecule drug substances and sterile drug products. Responsibilities include executing technical strategies, managing product lifecycle activities, and ensuring compliance with GMP standards. The role also involves supporting CMOs in audits, technical transfers, and continuous improvement initiatives.

GSK

On-site Permanent

Senior SME - MSAT EM Tech Ops DS DP

This role involves leading technical operations and providing strategic support for the commercial manufacture of large molecule drug substances and sterile drug products. Responsibilities include executing technical strategies, collaborating with external manufacturing partners, and ensuring compliance with GMP standards and continuous improvement initiatives.

GSK United States

On-site Permanent

Senior SME - MSAT EM Tech Ops DS DP

This role involves collaborating with internal and external stakeholders to support the commercial manufacture of large molecule drug substances and sterile drug products. Responsibilities include executing technical strategies, providing technical support, and ensuring compliance with GMP standards. The role also focuses on continuous improvement, change control, and managing critical lifecycle activities.

GSK

On-site Permanent

Associate Director, Diagnostic Planning Lead - Oncology

Leads diagnostic planning activities within oncology translational medicine, coordinating cross-functional teams and external partners to advance diagnostic development programs. Oversees project timelines, regulatory documentation, budget management, and strategic alignment, with a focus on biomarker technologies and IVD development in support of oncology assets.

GSK Stevenage, United Kingdom US$151,500 – US$252,500 pa

Hybrid Permanent

Associate Director, Diagnostic Planning Lead - Oncology

This role involves leading diagnostic planning for oncology projects within GSK’s Translational Medicine team, coordinating cross-functional activities across clinical development, regulatory, and external partners. The Associate Director will manage timelines, budgets, and deliverables for diagnostic development programs, ensuring alignment with biomarker strategies and regulatory requirements. The position plays a key strategic role in advancing oncology assets through integrated project management and collaboration with diagnostics manufacturers and internal stakeholders.

GSK London, United Kingdom US$151,500 – US$252,500 pa

Hybrid Permanent

Director, QC Systems

This role involves leading a global matrix programme team to transform incoming material testing and data management across GSK's manufacturing sites. Responsibilities include defining future-state operating models, creating global standards, and ensuring harmonised QC master data structures while partnering with various teams to implement the strategy.

GSK East Hertfordshire, United Kingdom

Hybrid Permanent

Director, QC Systems

This role involves leading a global matrix programme team to transform incoming material testing and data management across GSK's manufacturing sites. Responsibilities include defining future-state operating models, creating global standards, and ensuring harmonised QC master data structures while partnering with various teams to implement the strategy.

GSK Stevenage, United Kingdom

Hybrid Permanent