Latest regulatory affairs Jobs

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 £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 these into clinical plans to optimize decision-making and patient stratification.

GSK £189,750 – £316,250 pa

On-site Permanent

Specialist - Extractables and Leachable - MSAT EM

This role involves working with internal and external labs to ensure E&L testing is completed scientifically and compliantly. Responsibilities include conducting risk assessments, delivering technical information, and managing risk identification for biopharmaceutical manufacturing processes and packaging systems.

GSK United States £70,650 – £117,750 pa

On-site Permanent

Specialist - Extractables and Leachable - MSAT EM

This role involves working with internal and external labs to ensure E&L testing is completed scientifically and compliantly. Responsibilities include conducting risk assessments, delivering technical information, and managing risk escalation for biopharmaceutical manufacturing processes and packaging systems.

GSK £70,650 – £117,750 pa

On-site Permanent

Audit Senior Lead (EMEA GMP Audit)

The Audit Senior Lead role involves performing and managing GMP and compliance audits of biopharmaceutical, vaccine, and pharmaceutical facilities across the EMEA region. Key responsibilities include evaluating compliance, managing stakeholder engagement, and producing clear audit reports to mitigate risks and ensure regulatory adherence.

GSK

On-site Permanent

Audit Senior Lead (EMEA GMP Audit)

This role involves performing and managing GMP and compliance audits of biopharmaceutical, vaccine, and pharmaceutical facilities across the GSK Global Supply Chain. You will evaluate compliance with regulatory requirements and provide sterile manufacturing expertise, engaging with senior stakeholders and producing clear audit reports.

GSK

Hybrid Permanent

Audit Senior Lead (EMEA GMP Audit)

The Audit Senior Lead role involves performing and managing GMP and compliance audits of biopharm, vaccines, and pharmaceutical facilities. Responsibilities include evaluating compliance, managing stakeholder engagement, and producing clear audit reports. The role requires strong communication skills and subject matter expertise in sterile manufacturing.

GSK

On-site Permanent

Audit Senior Lead (EMEA GMP Audit)

This role involves performing and managing GMP and compliance audits of GSK's Biopharm, Vaccines, and Pharmaceutical facilities across EMEA and other highly regulated markets. Responsibilities include evaluating compliance, conducting various types of audits, and producing clear audit reports to inform senior management of identified risks and corrective actions.

GSK

Hybrid Permanent

Audit Senior Lead (EMEA GMP Audit)

This role involves performing and managing GMP and compliance audits of GSK's Biopharm, Vaccines, and Pharmaceutical facilities across EMEA and other highly regulated markets. You will evaluate compliance with GMP, regulatory requirements, and quality systems, and provide sterile manufacturing expertise. The role requires strong communication and stakeholder engagement skills.

GSK

Hybrid Permanent

Product Director, Evidence Preparation

The role involves leading the development and strategy of AI-enabled digital products for structured authoring and regulatory content across clinical, non-clinical, CMC, safety, and publications domains. The Product Director will drive innovation in automated content generation, modular reuse, and compliance within a GxP environment, working closely with cross-functional stakeholders and technical teams to scale enterprise-grade solutions.

GSK United Kingdom

Hybrid Permanent

Statistics Leader / Associate Director – Oncology Statistics

This role involves leading statistical planning and delivery for oncology clinical programs, working closely with cross-functional teams to design robust clinical trials and drive methodological innovation. You will mentor colleagues and contribute to regulatory strategy, using advanced statistical methods and simulations to inform trial design and risk assessment.

GSK

Hybrid Permanent

Statistics Leader / Associate Director – Oncology Statistics

This role involves leading statistical planning and delivery for clinical programs in oncology, working closely with cross-functional teams to design robust clinical trials and contribute to regulatory strategy. The position also focuses on methodological innovation and mentoring colleagues to build statistical capability and quality.

GSK

Hybrid 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 (RII) or Oncology Research Unit. The Head of RII or Oncology Programming will lead a global team, drive strategic initiatives, and champion innovation in clinical programming, ensuring high standards of quality, compliance, and timely delivery of medicines and vaccines.

GSK Stevenage, United Kingdom

On-site Permanent

Programming Leader

The Programming Leader role involves overseeing 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 the adoption of agile principles and new technologies to improve efficiency and data analysis.

GSK Stevenage, United Kingdom

Hybrid 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 new medicines and vaccines.

GSK United Kingdom

On-site Permanent