Associate Clinical Trials Regulatory ManagerEMEAHomebasedJob SummaryThe Associate Clinical Trials Regulatory Manager provides regulatory support and oversight for clinical trial submissions across general programs. This role is responsible for preparing and reviewing regulatory documentation, managing submissions, ensuring regulatory compliance, and supporting clients and internal stakeholders throughout the clinical trial lifecycle. This is not a people manager role, but a process management position.Key ResponsibilitiesServe as the Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects and programs.Review scientific and regulatory documentation, conduct gap analyses, and provide recommendations.Author and/or review key regulatory documents, including Investigational Medicinal Product Dossiers (IMPDs) and clinical trial justifications.Coordinate and support European centralized submissions and global country submissions.Ensure project deliverables are completed on time, within scope,



and in compliance with regulatory requirements.Maintain accurate records in internal systems, databases, and tracking tools in accordance with SOPs.Support business development activities by providing regulatory expertise.Deliver regulatory training and presentations as required.Mentor junior team members and contribute to departmental knowledge sharing initiatives.Qualifications and ExperienceBachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.Typically 3-5 years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, CRO, or clinical research industry.Experience supporting clinical trial submissions and regulatory documentation.Strong scientific writing, document review, project management, and stakeholder engagement skills.Advanced knowledge of clinical trial regulations and regulatory submission processes.Knowledge & CompetenciesAdvanced knowledge of regulatory affairs and clinical trial submission requireme

📌 Associate Clinical Trials Regulatory Manager, EMEA (Barcelona)
🏢 Cv-Library
📍 Barcelona