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, influencing regulatory outcomes, and driving cross-functional collaboration to embed intelligence into submission processes and templates.

GSK United Kingdom

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 processes and templates.

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 collaboration with internal and external stakeholders.

Pfizer United States

On-site Permanent

Clinical Development Medical Director (Associate Director)

This role involves overseeing the 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

On-site Permanent

Statistics Leader / Associate Director – Oncology Statistics

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares...

GSK United Kingdom

Statistics Leader / Associate Director – Oncology Statistics

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares...

GSK

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

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 East Hertfordshire, United Kingdom

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 lifecycle support, and ensuring compliance with GMP standards. The role also focuses on continuous improvement and managing technical transfers between contract manufacturing organizations (CMOs).

GSK East Hertfordshire, United Kingdom

On-site Permanent