420 jobs for “Pharmaceutical Quality Assessor”
Author and manage high-quality regulatory documents for medicines, working with cross-functional clinical and submission teams. Advise on regulatory writing standards, lead writing plans and timelines, and apply AI tools to improve quality and efficiency. Requires strong biostatistics understanding and global regulatory knowledge.
Artificial Intelligence
Manages regulatory activities for clinical trial applications across an assigned portfolio, leading high-quality submissions and coordinating responses to Health Authority queries. Works closely with study teams, country leads and cross-functional partners to identify regulatory risks early and secure timely approvals, while contributing to simplification and automation initiatives across Regulatory Affairs.
GSK · 10000+ people · Public
Leads global medical writing for the Respiratory, Immunology and Inflammation portfolio, directing strategy, resource planning and vendor oversight to deliver regulatory-compliant clinical documentation. Drives submission acceleration, digital innovation and cross-functional partnerships across R&D, with accountability for talent development and operational excellence.
Content Management Systems
Owns defined planning process areas within GSK's ERP Evolution Programme, ensuring the global S/4 Planning template integrates with OMP, APO and other planning tools across Rx and Vx supply chains. Leads design, configuration input, documentation, testing, data migration and business readiness for UAT, cutover and post-go-live support, working with SAP functional experts, GPO, PLM, Quality and site teams.
SAP ECC · S/4HANA · OMP +2
IQVIA
Leads strategic sourcing of animal models, especially rodents and genetically engineered strains, for an early-phase discovery business. Manages supplier relationships, RFIs/RFPs, contract negotiations and performance reviews, while partnering with scientific, veterinary and quality teams on capacity planning, welfare and regulatory compliance.
IQVIA
Supports clinical trials by designing, setting up and maintaining Interactive Response Technology (IRT) solutions, translating supply requirements into system specifications. Contributes to risk assessments, user acceptance testing and validation documentation, and advises study teams on IRT processes. Works with cross-functional global stakeholders on study startup, amendments and continuous improvement.
IRT · RTSM · IVRS +1
Eurofins
Performs routine, non-routine and stability testing of biologic drug substances using ELISA, cell-based potency assays and Biacore (SPR), while coordinating assay activities and managing project priorities and timelines. Acts as a technical subject matter expert, mentoring colleagues and supporting method development, validation, troubleshooting and GMP-compliant documentation within a client-facing analytical service department.
ELISA · Biacore · Vi-CELL +2
Thermo Fisher Scientific
Operates and sets up bulk formulation, filling, inspection and packing lines for sterile and non-sterile pharmaceuticals, following SOPs, BMRs and cGMP in a cleanroom environment. Performs CIP/SIP, autoclave and airlock operations, equipment monitoring and documentation, and provides team leadership on night shifts. Distinct for its aseptic manufacturing focus, hazardous materials handling and supervisory duties.
SAP · HMI · EDMS
Thermo Fisher Scientific
Clinical Research Associate role within PPD's Functional Service Provider division, dedicated to a client and embedded in multi-national project teams. You perform and coordinate all aspects of clinical monitoring, conducting monitoring activities independently across challenging projects. Requires ICH-GCP, EU and FDA knowledge, with award-winning training provided.
Isomorphic Labs · 201–500 people · Series A
Lead the safety assessment strategy for small molecule and biologic drug discovery projects from inception to regulatory submission, designing screening cascades and mechanistic experiments. Partner with machine learning researchers to build predictive toxicology models and manage CRO relationships for outsourced wet-lab data generation, while mentoring junior team members.
KNIME · Python
Isomorphic Labs · 201–500 people · Series A
Owns safety assessment strategy for drug discovery projects from inception to regulatory submission, working with small molecule and biologics platforms. Designs screening cascades, authors IND packages, and manages CRO relationships for outsourced wet-lab work. Also guides development of an AI predictive toxicology platform with ML researchers.
AI/ML · AlphaFold
Bicycle Therapeutics
Lead biophysical binding characterisation, predominantly using Surface Plasmon Resonance, to interrogate Bicycle® molecules and triage screening cascades. Design and optimise bespoke assays, explore orthogonal technologies such as Carterra, AlphaScreen and mass photometry, and partner with computational and structural biology teams on structure-based drug design. Mentors junior colleagues within the Platform Technology group.
SPR · Carterra · AlphaScreen +4
Fortrea
Prepare and handle investigational medicinal products in a cGMP clean room, applying sterile technique and GMP during live first-in-human studies. Work in pairs with Technical Officers on study set-up, dose calculations, batch records and equipment checks, with the clinic and pharmacy under one roof at an MHRA-accredited Phase I unit.
Outlook · Word · Excel +1
Bristol Myers Squibb
As a member of cross-functional development teams, you will contribute to trial design, protocol development, analysis planning, and regulatory submissions, with the option to support a specific asset indication. The role involves authoring statistical analysis plans and clinical study reports, defending protocols at governance reviews, and providing statistical leadership on health authority requests. It requires 50% onsite presence in Uxbridge and proficiency in SAS, R, or Python.
SAS · R · Python
Autolus · 101–500 people · Series C
Accountable for onboarding and ongoing performance management of apheresis and treatment centres supporting clinical and commercial CAR T-cell therapies across the UK and Rest of World. Serves as the technical operations single point of contact, conducting site assessments, training centre staff, supporting quality systems and deviations, and managing process change rollouts. Involves up to 50% travel and possible management of contract employees.
Electronic Data Management Systems
