Job Description Join our team of experts, providing support in all regulatory aspects of clinical studies. You will be part of a dedicated team committed to quality and timelines, ensuring the smooth initiation and conduct of projects involving novel pharmaceutical products. We are currently seeking someone who will take ownership of serious breach administration tasks within the regulatory framework and support clinical study submissions, approvals, and compliance activities specific to the United Kingdom. You will: Support PSIs global serious breach group by documenting, filing and tracking potential cases of serious breaches of GCP, applicable regulations and/or the approved trial protocol Track regulatory project documentation flow and progress reporting Liaise with project team to procure documents necessary for regulatory and ethics committee submissions, ensuring these meet local requirements. Prepare submission dossiers within planned timelines and submit to the authority and ethics committee. Review investigational product release-enabling documents. Maintain regulatory study lifecycle, manage changes in the study as applicable (by means of submitting notifications/supplemental applications). Deliver regulatory training to project teams. Assist with feasibility research and business development requests, if requested. Manage safety reporting to authorities