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Regulatory Manager - Pharmaceuticals
The closing date is 23 July 2025
Are you a pharmacist with clinical trials experience? Are you passionate about advancing clinical research and want to play an expert role in the development of new therapies? Join our expert CTIMPs team at UCL and help shape the future of clinical trials.
We're looking for a highly motivated specialist pharmacist to take on a key regulatory role in the delivery of UCL-sponsored Clinical Trials of Investigational Medicinal Products (CTIMPs). In this dynamic and collaborative position, you will work closely with specialist trial teams, regulatory bodies, and industry partners to ensure our trials are setup to the highest standards of compliance and innovation.
As the regulatory pharmaceutical expert, you will support senior members of the team on all aspects of IMP sourcing, manufacturing oversight, and supply chain management, supporting trials from early concept through to delivery at clinical sites. You will be the primary contact with pharmaceutical companies, Contract Development and Manufacturing Organisations (CDMOs), and other stakeholders providing regulatory strategy for UCL-sponsored studies.
This role is an exciting opportunity to build deep expertise in the regulatory and CMC (Chemistry, Manufacturing and Control) landscape of early-phase clinical trials. You will ensure compliance with UK medicines regulations, including GCP, and GMP, while also providing specialist support for pharmacy-related queries across Phase I-III trials.
Main duties of the job
The post holder will provide expert regulatory and IMP support for UCL-sponsored CTIMPs, with a focus on trials where the sponsor is responsible for IMP supply. You will work with study teams to define IMP supply chains, provide regulatory and sourcing strategy, and determine documentation requirements for CTA submissions based on study phase and complexity. The role includes reviewing and approving GMP documents (e.g. labels), leading on the development and review of quality agreements with pharmaceutical companies and CDMOs.
The post holder will support on complex regulatory queries, particularly for early-phase and first-in-human trials, including cell and gene therapies. They will also act as a key point of contact for stakeholders on pharmaceutical aspects of UCL-sponsored studies and support site set-up through direct engagement with site pharmacies. This includes responding to IMP-related queries and working closely with the Principal Clinical Trials Pharmacist at UCLH. Strong communication, sound regulatory judgment, and the ability to manage complex stakeholder relationships are essential.
About us
University College London Hospitals NHS Foundation Trust (UCLH) is one of the most complex NHS trusts in the UK, serving a large and diverse population. We provide academically led acute and specialist services, to people from the local area, from throughout the United Kingdom and overseas. Our vision is to deliver top-quality patient care, excellent education, and world-class research. We provide first-class acute and specialist services across eight sites:
University College Hospital (incorporating the Elizabeth Garrett Anderson Wing)
National Hospital for Neurology and Neurosurgery
Royal National ENT and Eastman Dental Hospitals
University College Hospital Grafton Way Building
Royal London Hospital for Integrated Medicine
University College Hospital Macmillan Cancer Centre
The Hospital for Tropical Diseases
University College Hospital at Westmoreland Street
We are dedicated to the diagnosis and treatment of many complex illnesses. UCLH specialises in women's health and the treatment of cancer, infection, neurological, gastrointestinal and oral disease. It has world class support services including critical care, imaging, nuclear medicine and pathology.
We are committed to sustainability and have pledged to become a carbon net zero health service, embedding sustainable practice throughout UCLH. We have set an ambitious target of net zero for our direct emissions by 2031 and indirect emissions by 2040.
Job responsibilities
For the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description.
Come and be a part of the best NHS trust in England to work for, according to our staff*
* UCLH top trust to work at in England - In the most recent NHS staff survey UCLH had the highest percentage of staff who said they would recommend us as a place to work, out of all general acute or acute/community NHS trusts in England for the third year in a row.
UCLH recognises the benefits of flexible working for staff To find out more, visit: Flexible working.
To discover more about what makes UCLH a great place to work, visit: Why Choose UCLH?
Person Specification
Knowledge and Qualifications
* Masters Degree (or equivalent) in Pharmacy
* Knowledge of Clinical Trials regulations gained through pharmacy or equivalent on work experience
* Knowledge of the processes required to setup and conduct clinical trials from IMP sourcing, manufacturing or management perspective
Experience
* Significant hospital pharmacy experience acquired through post-registration work
* GMP and/or GCP experience gained in hospital or pharmaceutical industry
* Familiar with aseptic preparation and/or sterile manufacturing processes
* Documented commitment to continued professional development
* Working with innovative medicines including ATMPs
Skills and Abilities
* Trained in principles of Good Clinical Practice and Good Manufacturing Practice
* Ability to formulate suitable solutions where current practice and evidence is uncertain
* Ability to work without supervision and use own initiative
Values
* Demonstrate ability to meet Trust Values of safety, kindness, teamwork and improving
Communication
* Excellent verbal and written communication skills
Personal and People Development
* Be able to deliver training IMP management sessions for JRO and CTU Staff
* Be able to communicate effectively and with confidence to internal and stakeholders in relation to pharmaceutical aspects and associated regulatory requirements
Ensure the risk of infection to self, colleagues, patients, relatives and visitors is minimised by:
* Being familiar with, and adhering to Trust policies and guidance on infection prevention and control.
* Completing all required training and education (both via e-learning and face to face) on infection prevention and control.
* Including infection prevention and control as an integral part of your continuous personal/professional development and included in your annual appraisal
* Taking personal responsibility so far as is reasonably practicable, in helping ensure that effective prevention and control of health care associated infections is embedded into everyday practice and applied consistently.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
University College London Hospitals NHS Foundation Trust
Address
University College London Hospitals NHS Foundation Trust
£61,927 to £68,676 a yearper annum inclusive of HCAS
Contract
Fixed term
Duration
12 months
Working pattern
Full-time
Reference number
309-UCLH-6560
Job locations
University College London Hospitals NHS Foundation Trust
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