13 ago
|
Talent
|
Barcelona
Experteer Overview
In this role you support regulatory submissions and oversight for general clinical trial programs. You will prepare and review regulatory documentation, ensure compliance, and coordinate submissions for Europe and beyond. You work with cross-functional stakeholders to keep projects on track and deliver high-quality regulatory outputs. The position blends process management with regulatory acumen to enable timely trial progress and client satisfaction. This is a hands-on, non-managerial role that emphasizes reliability, collaboration, and continuous knowledge sharing.
Compensaciones / Beneficios
• Serve as CTRM on complex clinical trial projects and programs
• Provide regulatory oversight and strategic guidance to internal and external stakeholders
• Review scientific and regulatory documentation, perform gap analyses, and make recommendations
• Author and/or review IMPDs and clinical trial justifications
• Coordinate and support European centralized submissions and global country submissions
• Ensure deliverables are on time, within scope, and compliant
• Maintain records in internal systems and SOP-compliant procedures
• Support business development with regulatory expertise
• Deliver regulatory training and presentations
• Mentor junior team members and contribute to knowledge sharing
Responsabilidades
• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field
• Typically 3–5 years of regulatory affairs experience in pharma, biotech, CRO, or clinical research
• 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 submission processes
Requisitos principales
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📌 Associate Clinical Trials Regulatory Manager, EMEA (Barcelona)
🏢 Talent
📍 Barcelona