Regulatory Manager - Pharmaceuticals

This job is brought to you by Jobs/Redefined, the UK\’s leading over-50s age inclusive jobs board.

The use of AI is monitored and if applicants have used it, then they are required to declare this in their supporting statement.

Job overview

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.

Working for our organisation

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.

Detailed job description and main 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

Essential criteria

• 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
• Continuing professional development

Experience

Essential criteria

• 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

Desirable criteria

• Working with innovative medicines including ATMPs

Skills and Abilities

Essential criteria

• Trained in principles of Good Clinical Practice and Good Manufacturing Practice
• Ability to formulate suitable solutions where current practice and evidence is uncertain
• Excellent Presentation skill Project management skills
• Ability to work without supervision and use own initiative

Values

Essential criteria

• Demonstrate ability to meet Trust Values of safety, kindness, teamwork and improving

Communication

Essential criteria

• Excellent verbal and written communication skills

Personal and People Development

Essential criteria

• 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:

Essential criteria

• 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.

At UCLH, we have a real \’One Team\’ ethos, and our values – safety, kindness, teamwork and improving, are central to the way we work. This is supported by our staff, who voted us as the #1 NHS Acute Trust to work for in the whole of England.

At UCLH we take equality of opportunity seriously and are committed to being a diverse and inclusive employer, with a culture that creates a real sense of belonging and trust. It is our fundamental aim, to recruit, retain and promote a diverse mix of people who are representative of our local communities. Applications are encouraged from candidates of all backgrounds, cultures, and perspectives to support our world class research, innovation and creativity.

UCLH recognises the benefits of flexible working for staff and has a dedicated policy which allows staff to apply for flexible working right from the beginning of employment. For more information please go to: .

We offer our permanent staff an interest free season ticket loan for travel, all our staff have access to free independent and confidential support, large retail discounts, a staff discount platform, cycle to work scheme and on-site accommodation to name a few.

Additionally, UCLH Arts and Heritage\’s staff wellbeing programme, Creative Comfort, offers a variety of ways to engage with the arts as a member of UCLH staff. You can try out the weekly choir, weekly art club and join the Culture Club for exclusive access to free and discounted tickets for opera, exhibitions, theatre and more.

We recognise, reward and thank colleagues by nominating them for our annual Celebrating Excellence Awards, which are funded by UCLH Charity.

We are also members of which offers discounts on high street retail stores, offers on travel deals, and also to take advantage of cash back schemes.

This vacancy may close before the current listed closing date. You are advised not to delay submitting your completed application.

Please note that all correspondence regarding your application will be via email. The emails will be sent to you via TRAC.jobs and not via NHS Jobs, we encourage you to check your inbox regularly.

Please note that if you are at present in a training position on the 2016 new junior doctor\’s contract and are applying for a Trust doctor role your salary will not be pay protected.

You will be placed on the appropriate point of the Trust Doctor pay scale based on your previous experience.

Please note that if you have not heard from us within 3 weeks of the closing date of the advert to assume that you have not been shortlisted on this occasion.

The Trust uses electronic new starter forms on Trac to collect personal details. Information collected is securely stored and used to set up the employee record on the ESR HR system.

For further support on submitting an application please refer to the NLPSS Applicant Toolkit:

Employer certification / accreditation badges

Applicant requirements

You must have appropriate UK professional registration.

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

Documents to download

• Job Description (PDF, 736.3KB)
• Functional Requirements (PDF, 262.3KB)
• UCLH Values (PDF, 860.9KB)

#J-18808-Ljbffr