Latest regulatory affairs Jobs

Senior Director, Global Health Outcomes, ViiV Healthcare

This role involves leading the global health outcomes function at ViiV Healthcare, focusing on evidence generation to support HIV treatment and prevention medicines. Responsibilities include strategic leadership, team management, and collaboration with various stakeholders to ensure credible and decision-relevant evidence for patient access and value demonstration.

GSK United Kingdom

On-site Permanent

Senior Director, Global Health Outcomes, ViiV Healthcare

This role involves leading the global health outcomes function at ViiV Healthcare, designing and delivering robust evidence to support HIV treatment and prevention medicines. Responsibilities include strategic leadership, evidence generation, and collaboration with various stakeholders to optimize patient access and value demonstration.

GSK

On-site Permanent

Regional Regulatory Intelligence Manager

This role involves leading the regional regulatory intelligence strategy, ensuring alignment with global regulatory direction and Health Authority expectations. Responsibilities include identifying and translating regulatory intelligence into actionable insights, influencing regulatory outcomes, and driving cross-functional collaboration to embed intelligence into submission processes and templates.

GSK

Hybrid Permanent

Regional Regulatory Intelligence Manager

This role involves leading the regional regulatory intelligence strategy, ensuring alignment with global regulatory direction and Health Authority expectations. Responsibilities include identifying and translating regulatory intelligence into actionable insights, driving cross-functional collaboration, and supporting capability building and training.

GSK

Hybrid Permanent

Regional Regulatory Intelligence Manager

This role involves leading the regional regulatory intelligence strategy, ensuring alignment with global regulatory direction and Health Authority expectations. Responsibilities include identifying and translating regulatory intelligence into actionable insights, influencing regulatory outcomes, and driving cross-functional collaboration to embed intelligence into submission content and processes.

GSK

Hybrid Permanent

Quality Validation and CSV Manager

The Quality Validation and CSV Manager will lead a team responsible for ensuring all validation activities, including process, cleaning, facility, and computer systems validation, comply with regulatory requirements and GSK quality standards. The role involves managing validation protocols, collaborating with cross-functional teams, and providing technical expertise and training.

GSK Barnard Castle, United Kingdom

On-site Permanent

Principal Medical Writer

This role involves authoring and delivering high-quality clinical regulatory documents, leading cross-functional teams, and managing complex writing projects. The Principal Medical Writer will interpret clinical and statistical data, ensure compliance with regulatory requirements, and contribute to global regulatory submissions.

GSK Stevenage, United Kingdom

Hybrid Permanent

Principal Medical Writer

The Principal Medical Writer will author and deliver high-quality clinical regulatory documents, lead cross-functional teams in developing clinical dossier documents for global regulatory submissions, and manage complex writing projects. They will interpret complex clinical and statistical information, ensuring compliance with GSK standards and regulatory requirements.

GSK

Hybrid Permanent

Engineering Technician (6-month Secondment / Fixed-Term

The Engineering Technician role involves providing technical support for the Dermatologicals Filling and Packaging function, including equipment maintenance, GMP compliance, and continuous improvement initiatives. The position operates on a 16/5 shift rota and is a 6-month fixed-term contract.

GSK Barnard Castle, United Kingdom

On-site Contract Shift-work

Director, Precision Diagnostics - Oncology

This role leads the development and execution of precision diagnostics strategies for oncology programs, integrating biomarker and assay development across clinical trials. The position involves cross-functional leadership to align diagnostic solutions with therapeutic assets, manage regulatory requirements, and partner with external diagnostic companies and labs. It focuses on advancing patient-centric innovation by ensuring the right therapies reach the right patients through robust diagnostic frameworks.

GSK Stevenage, United Kingdom US$189,750 – US$316,250 pa

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 strategies. The position also focuses on methodological innovation and mentoring colleagues to build statistical capability and quality.

GSK Stevenage, United Kingdom

Hybrid Permanent

Quality Manager (on Shift)

The Quality Manager on Shift ensures compliance with GMP and regulatory requirements during manufacturing and non-manufacturing activities. Key responsibilities include monitoring quality systems, investigating deviations, and supporting product release. The role involves working in a 24/5 shift pattern, including weekends, and promoting team collaboration and continuous improvement.

GSK East Hertfordshire, United Kingdom

On-site Permanent Shift-work

Specialist - Extractables and Leachable - MSAT EM

This role involves leading Extractables and Leachables (E&L) assessments for biopharmaceutical manufacturing processes, container closure systems, and dosing devices. The Specialist will work with internal and external labs to ensure E&L testing is completed scientifically, compliantly, and cost-effectively, while also managing risk identification and escalation.

GSK East Hertfordshire, United Kingdom £70,650 – £117,750 pa

On-site Permanent

Senior Engineering Technician (Secondment)

As a Senior Engineering Technician, you will provide comprehensive engineering support for the Sterile Value Stream, ensuring all production processes meet business and regulatory requirements. You will lead and supervise the Engineering Technician team, manage equipment breakdowns, and drive continuous improvement initiatives in a shift-based environment.

GSK Barnard Castle, United Kingdom

On-site Contract Shift-work

Audit Senior Lead (EMEA GMP Audit)

This role involves performing and managing GMP and compliance audits of Biopharm, Vaccines, and Pharmaceutical facilities. You will evaluate compliance with GMP, policies, and regulatory requirements, and provide subject matter expertise on sterile manufacturing. The role requires strong communication and influencing skills, and involves travel to various sites across the network.

GSK East Hertfordshire, United Kingdom

Hybrid Permanent