Job OverviewIndividual contributor with advanced knowledge acquired from at least 8 years of relevant industry experience. Working independently with limited supervision, the individual will provide strategic regulatory expertise and leadership for clinical trial applications and lifecycle management activities, with a strong focus on EU Clinical Trials Regulation (CTR) submissions and Clinical Trials Information System (CTIS) management. Essential FunctionsAct as Regulatory General Team Leader for regulatory projects and/or serve as Regulatory Project Manager for stand-alone projectsLead the preparation, review, and submission of regulatory documentation, ensuring high quality and compliance with applicable regulations and guidelinesProvide strategic regulatory advice to clients, including EU submission strategy, Reporting Member State (RMS) selection, scientific advice planning, and lifecycle management activitiesLead and support EU CTR submissions, including initial CTA submissions, substantial modifications, Requests for Information (RFIs),



and CTIS lifecycle activitiesManage communications and interactions with regulatory authorities, including support for and participation in agency meetings.
Build and maintain strong client relationships, acting as a trusted advisor on regulatory matters and proactively resolving issuesManage project timelines, deliverables, budgets, and out-of-scope activities to ensure successful project execution and financial performanceMentor and provide guidance to junior colleagues, including review of regulatory documentation and support for training and professional developmentSupport business development activities, including travelling to and participating in bid defense meetings and client presentationsContribute to the development, revision, and review of regulatory and cross-functional Standard Operating Procedures (SOPs)Support global, regional, and cross-functional regulatory initiatives and process improvement activitiesRemain

📌 Regulatory Affairs Manager (Barcelona)
🏢 The BIG Jobsite
📍 Barcelona