Regulatory Manager - Pharmaceuticals
Job Description
Job summary
This is an exciting opportunity to join a growing pharmaceutical regulatory function within one of the UK's leading academic research organisations. As UCL's clinical trial portfolio continues to expand, we are recruiting to an additional Regulatory Manager - Pharmaceuticals post to strengthen the team and support the next generation of groundbreaking therapies and technologies.
We are looking for a highly specialist pharmacist with experience in clinical trials, pharmaceutical manufacturing, or regulatory affairs and someone who is passionate about advancing clinical research and helping bring innovative therapies from development to patients.Working closely with trial teams, regulators and industry partners, you will help ensure studies are delivered on behalf of UCL sponsored studies.
As the regulatory pharmaceutical expert, you will support all aspects of IMP sourcing, manufacturing, Chemistry, Manufacturing and Control (CMC) strategy, and regulations across Phase 1-3 clinical trials.
This role offers an excellent opportunity to develop expertise in the regulatory and CMC aspects of clinical trials, particularly early-phase and innovative therapies. You will support compliance with UK and EU regulations, GCP and GMP requirements, while providing specialist pharmaceutical advice to investigators and study teams. This is an exciting opportunity to work at the forefront of clinical research within a world-leading academic institution.
Main duties of the job
The post holder will provide expert regulatory, pharmaceutical and IMP support for UCL-sponsored CTIMPs, particularly studies where the Sponsor is responsible for IMP manufacture and supply. Working closely with study teams, they will support the development of CMC strategies, including manufacturing, testing, release and supply chain models, identification of suitable pharmaceutical vendors and CDMOs, and determination of CTA documentation requirements based on study phase, product type and complexity.
The role includes reviewing and approving GMP and pharmaceutical documentation, supporting responses to regulatory authority queries, and providing advice on complex CMC and regulatory challenges. The post holder will lead on the development and review of quality agreements and oversight of outsourced manufacturing and testing activities.
The post holder will support complex studies, including early-phase and first-in-human trials involving cell and gene therapies, biologics, radiopharmaceuticals and small molecules. They will act as a key point of contact for investigators, trial teams, manufacturers and site pharmacies on pharmaceutical and regulatory matters.
The role also includes participation in the UCL JRO Scope Review Committee, supporting classification of studies as CTIMPs or non-CTIMPs. Subject to funding, the post holder may undertake national and international travel, including GMP audits and due diligence assessments of manufacturing and testing facilities.
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
Specific Requirements
Essential
- Ability to travel between UCH and UCL sites if required.
Desirable
- Ability to travel to external vendors/CMOs sites nationally and international as and when required
Knowledge and Qualifications
Essential
- 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
- 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
- Working with innovative medicines including ATMPs
Skills and Abilities
Essential
- 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
- Demonstrate ability to meet Trust Values of safety, kindness, teamwork and improving
Communication
Essential
- Excellent verbal and written communication skills
Ensure the risk of infection to self, colleagues, patients, relatives and visitors is minimised by:
Essential
- 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.
Certificate of Sponsorship
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab) .
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab) .
UK Registration
Applicants must have current UK professional registration. For further information please see ...
