.Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences.As our organisation continues to grow we are hiring a Regulatory and Start Up Specialist/ Senior Regulatory and Start Up Specialist to join our team in Spain. This position can be offered fully home based.Essential functions of the job include but are not limited to:Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.Interaction with CA/EC for study purposes and handling responses to the CA/EC.Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team.Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership informed.Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release.Customize country/site specific Patient Information Sheet and Informed Consent Form.Responsible for/facilitates the translation and co-ordination of translations for documents.Maintain communication with other key functions participating to country start up e.G., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department