Latest regulatory affairs Jobs

Clinical Sciences Manager, Global Collaborative Studies – ViiV Healthcare 10 month maternity cover

This role involves leading and managing ViiV Healthcare's supported studies, including investigator-sponsored and collaborative studies. Responsibilities include reviewing study proposals, ensuring compliance with policies, and maintaining strong relationships with external investigators and internal stakeholders.

GSK United Kingdom

On-site Temporary

Clinical Sciences Manager, Global Collaborative Studies – ViiV Healthcare 10 month maternity cover

This role involves leading and managing ViiV Healthcare's supported studies, including investigator-sponsored and collaborative studies. Responsibilities include managing study proposals, ensuring compliance, and building relationships with external investigators and internal stakeholders. The role is crucial for generating evidence to inform HIV treatment and advancing ViiV's mission.

GSK

On-site Temporary

Global Development Lead, Early Clinical Development, Internal Medicine

The Global Development Lead will drive clinical research for cardiometabolic diseases, creating and executing early clinical development strategies. They will work closely with cross-functional teams to translate pre-clinical observations into clinical experiments, ensuring medical and scientific excellence in Phase 1/2 studies and regulatory submissions.

Pfizer London, SW7 2AP, United Kingdom

Hybrid Permanent

Clinical Development Medical Director (Associate Director)

This role involves overseeing medical and scientific aspects of clinical trials in Internal Medicine, including medical monitoring, safety data review, and clinical data management. The position also includes mentoring others and contributing to protocol design and study strategy.

Pfizer Manchester, M1 4HD, 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

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

Head of Precision Diagnostics External Engagement

This senior role involves leading business development and transactions in biomarker and diagnostics for GSK's Oncology R&D. Responsibilities include negotiating deals, aligning with R&D strategy, and collaborating with internal and external stakeholders to drive strategic alliances and complex collaborations.

GSK Stevenage, United Kingdom £242,250 – £403,750 pa

On-site Permanent

Head of RTSM (Randomization and Trial Supply Management)

This role involves leading the RTSM function, partnering with clinical development, operations, quality, and external vendors to design and deliver patient-focused randomization and clinical supply solutions. Responsibilities include managing cross-functional teams, ensuring on-time randomization and supply availability, and improving RTSM processes and governance.

GSK Stevenage, United Kingdom

Hybrid Permanent

Statistics Director, Oncology

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

GSK Stevenage, United Kingdom

On-site 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 Stevenage, United Kingdom £87,000 pa

Hybrid Permanent

SERM Scientific Director, Oncology

The SERM Scientific Director role involves leading pharmacovigilance and risk management strategies for clinical development and post-marketing products. Responsibilities include evaluating safety data, managing safety concerns, and supporting regulatory activities. The role operates in a global, cross-functional environment and may include mentoring responsibilities.

GSK United Kingdom

Hybrid Permanent