Latest regulatory affairs Jobs

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

Clinical Development Medical Director (Associate Director)

This role involves overseeing medical and scientific aspects of clinical trials in Internal Medicine, ensuring data integrity and quality. Responsibilities include medical monitoring, safety data review, protocol development, and providing clinical support to study teams and investigators.

Pfizer

On-site Permanent

Clinical Development Medical Director (Associate Director)

This role involves overseeing medical and scientific aspects of clinical trials in Internal Medicine, ensuring data integrity and quality. Responsibilities include medical monitoring, safety data review, protocol development, and providing clinical support to study teams and external stakeholders.

Pfizer

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

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

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

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 the EMEA region. You will evaluate compliance with GMP, regulatory requirements, and quality management systems, and provide subject matter expertise in sterile manufacturing. The role requires strong communication and influencing skills to engage with senior stakeholders and produce clear audit reports.

GSK Worthing, United Kingdom

Hybrid Permanent

Audit Senior Lead (EMEA GMP Audit)

The Audit Senior Lead role involves performing and managing GMP and compliance audits of GSK's Biopharm, Vaccines, and Pharmaceutical facilities. Responsibilities include evaluating compliance, conducting various types of audits, and producing clear audit reports to inform senior management of risks and corrective actions.

GSK Barnard Castle, United Kingdom

Hybrid Permanent

Engineering Technician

The Engineering Technician role involves providing comprehensive engineering support for the Steriles Business Unit, focusing on equipment maintenance, GMP compliance, and continuous improvement initiatives. Responsibilities include breakdown repairs, calibration, quality documentation, and project support, all while maintaining high safety and regulatory standards.

GSK Barnard Castle, United Kingdom

On-site Permanent Shift-work

Operational Quality Director

The Operational Quality Director at GSK will lead the end-to-end quality oversight of manufacturing activities, ensuring compliance with GMP standards and regulatory requirements. Key responsibilities include managing batch documentation, overseeing real-time quality control, and leading the QP team to maintain high-quality standards and inspection readiness.

GSK East Hertfordshire, United Kingdom

On-site Permanent