As a Regulatory Manager you'll play a crucial role in working with other specialist trials staff, the post holders Working with other specialist trials staff, the post holder is expected to provide pharmaceutical and regulatory expertise and support to ensure that Clinical Trials of Investigational Medicinal Products sponsored by UCL are setup and conducted to comply with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), all other relevant medicines regulations and ethical requirements. UCL operates on a flexible/hybrid working arrangement with around 40% in office and 60% at home however this is open to negotiation.
In this role, you can expect to:
- Manage, co-ordinate and develop the IMP supply service for clinical trials run in both Europe, the UK and low and middle Income countries in order to ensure, a safe, consistent and legally compliant supply.
- Act as support for the project managers across the Drug Supply process, liaising with pharmaceutical companies, importers, suppliers, laboratories and investigators ensuring the procurement and supply of IMPs for sponsored clinical trials.
- Proactively identify issues, identify risk in the supply chain and develop appropriate risk management strategies, tools and procedures and provide solutions to ensure projects remain on schedule. This is a complex task as the background information is uncertain and changeable with very limited prediction tools available.
- Work in close collaboration with Contracts teams and project managers to provide specialist technical review and ensure contracts are executed in timely manner
- Contribute to the creation and or review and approvals of IB, Protocols, IMPD (CMC section of the IND) for sponsored trials in particular for novel products and ATIMPs
- Contribute to the creation, review and approvals of Technical File and Design Dossier for sponsored trials including advising on the regulatory strategy
- Liaise closely with and provide regular status updates to the trial teams and any pharmaceutical collaborators.
- As required, advise the dispensary, manufacturing and aseptic units, research nurse, Investigators, in order to provide support for the preparation of pharmacy standard operating procedures, dispensing guidelines, preparation of worksheets and labels and investigating the practical aspects of preparing doses, including the availability of stability data, to ensure effective IMP supply and treatment in a Trial.
We're looking for candidates who have:
- Masters Degree (or equivalent) in Pharmacy
- Knowledge of Clinical Trials pharmacy acquired through further training or equivalent on work experience.
- Previous experience as a Clinical Trial Pharmacist
- Documented commitment to continued professional development
- Significant pharmacy experience acquired through post-registration work
- Experience of development of ATMP therapies and other Early phase trials.
- Knowledge of regulatory requirements for ATIMPs in clinical trials.
- Knowledge of the processes required to setup and conduct clinical trials.
- 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 critically analyse research literature and synthesise and develop new robust procedures from analysis.
- Demonstrates innovation ability to work without supervision and use own initiative.
- Excellent verbal and written communication skills.
- Ability to work as part of a multidisciplinary team
With UCL being amongst the best universities in the world, it is such a great place to work.
You will receive a variety of benefits including weekly pay, a monthly recognition scheme, refer a friend scheme and visibility on potential permanent opportunities at UCL.
Guidant Global is acting as an Employment Agency in relation to this vacancy.