Reference Number: JO-2308-520569
Regulatory CTA Lead
Job Type: Permanent
Location: Central London / West End
Regulatory Affairs Lead – Clinical Trials
Locations – UK (Remote)
Regulatory Affairs Lead opportunity working for cutting-edge Oncology focused businesses conducting early- and late-phase trials globally.
In this role, you must be based in the UK and will have the flexibility to be 100% remote. As a Regulatory Lead, you will be a senior figure within the organisation and will have line management responsibilities for a small team.
In this position, you will be very hands-on and will be driving all clinical trials across all phases. You will be defining all strategies and working very cross-functionally within the business.
· Leading all regulatory strategies including a strong understanding of drug development to be able to support PIPS and ODD.
· Handle all complex clinical trials across phases 1 to 4 including supporting SSU activities.
· Management, preparation, and assemble of the Master Core Dossier and submissions of European: Clinical Trial Authorisation Applications (CTAA) and amendments and country-level Informed Consent and other patient-facing documentation.
· Leading all CTR submissions and transitions including excellent knowledge/understanding of CTIS.
· Tracks, reports and files CTAA and amendment submissions/approval progress in electronic trial master files (eTMF) clinical trials management system (CTMS) or other applicable systems.
· Supports clients in preparing for advice meetings with national RAs or the European Medicines Agency.
· Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by IECs and CA’s.
· Support and manage a small regulatory affairs team and offer training and mentoring.
· Bachelor’s degree required preferably in a life science field or equivalent.
· At least 8 years of industry experience including a wealth of CTA experience across all phases.
· Previous line management experience, or extensive mentoring/ training responsibilities.
· Experience working on clinical trials across all phases including leading a CTR submission.
· Prior experience in a CRO/pharmaceutical environment required.
· Previous Oncology experience.
If you are interested in this role or would like more details please email your CV to email@example.com
Remember if this role is not suitable for you please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.