Latest regulatory affairs Jobs

Senior Director, Head of Global Medical Governance, ViiV Healthcare

This role involves leading the global medical governance system at ViiV Healthcare, ensuring compliance and ethical standards across all medical activities. Responsibilities include developing and maintaining governance policies, advocating for medical governance, and collaborating with regional teams to embed best practices.

GSK United Kingdom

On-site Permanent

Senior Director, Head of Global Medical Governance, ViiV Healthcare

This role involves leading the global medical governance system at ViiV Healthcare, ensuring ethical and compliant medical practices across the organization. Responsibilities include developing and maintaining governance policies, advocating for medical governance, and collaborating with regional and local teams to embed robust practices.

GSK

On-site Permanent

Clinical Development Scientist, Manager

The Clinical Development Scientist (Manager) role involves providing scientific oversight and support for clinical trials in Internal Medicine. Responsibilities include protocol development, data review, safety monitoring, and contributing to clinical documents and reports. The role also involves collaborating with various stakeholders, including investigators, regulatory bodies, and safety review teams.

Pfizer

On-site Permanent

Cluster HTA Hub Senior Manager

In this role, you will develop and lead complex projects, manage economic research studies for clinical trials, and formulate research plans to enhance the value of Pfizer's medicines. You will collaborate with sales teams and utilize health economic models to maximize sales and improve customer interactions.

Pfizer Poland

On-site 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 £242,250 pa

On-site 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 successful collaborations and strategic alliances.

GSK £242,250 – £403,750 pa

On-site Permanent

Head of Precision Diagnostics External Engagement

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

GSK £242,250 pa

On-site Permanent

Pharmacovigilance Quality Assurance Director

This senior role involves leading and maintaining a robust pharmacovigilance quality assurance programme, ensuring compliance with global regulations and internal standards. Key responsibilities include overseeing PV processes, managing audits, and providing strategic guidance to ensure patient safety and continuous improvement.

GSK United Kingdom

Hybrid Permanent

Head of RTSM (Randomization and Trial Supply Management)

This role involves leading the RTSM function in the US, 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, risk assessments, process improvements, and fostering collaboration across internal and external partners.

GSK United States

Hybrid 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

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

Study Manager

The Study Manager role involves leading and coordinating clinical and evidence generation studies, working with internal and external teams to ensure studies are on time, on budget, and compliant with standards. Key responsibilities include monitoring study progress, drafting clinical documents, coordinating meetings, and managing study communications and supplies.

GSK Stevenage, United Kingdom

Hybrid Permanent

Director Medical Writing Process Management

The Director Medical Writing Process Management will lead the optimization of end-to-end business processes within Medical Writing, ensuring compliance, efficiency, and continuous improvement. They will collaborate with cross-functional teams to implement best practices, monitor process health, and align with GSK’s strategic goals.

GSK Stevenage, United Kingdom

On-site Permanent

MSAT Drug Product Lead (Parenteral Products)

This role involves managing the technical delivery of drug product manufacturing, primarily for GSK's sterile injectable products. Responsibilities include leading New Product Introduction (NPI), technology transfers, process verification, and regulatory submissions. The position requires strong technical expertise, collaboration across functions, and a focus on quality and compliance.

GSK East Hertfordshire, United Kingdom

On-site Permanent