IQVIA
10,000+ employees
💼 Consulting
🏭 Manufacturing
📣 Marketing
💰 $1G Post-IPO Debt on 2023-05
Consulting • Manufacturing • Marketing
IQVIA is a global leader in data analytics and technology solutions, dedicated to improving health outcomes. The company utilizes its Connected Intelligence platform to harness the power of advanced data analytics and artificial intelligence, facilitating innovation in healthcare. IQVIA focuses on various areas, including clinical research, technology, and consulting services to solve complex healthcare challenges and accelerate the delivery of new therapies to patients.
Associate Clinical Trials Regulatory Manager
🔥 0 minutes ago
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IQVIA
10,000+ employees
💼 Consulting
🏭 Manufacturing
📣 Marketing
💰 $1G Post-IPO Debt on 2023-05
Consulting • Manufacturing • Marketing
IQVIA is a global leader in data analytics and technology solutions, dedicated to improving health outcomes. The company utilizes its Connected Intelligence platform to harness the power of advanced data analytics and artificial intelligence, facilitating innovation in healthcare. IQVIA focuses on various areas, including clinical research, technology, and consulting services to solve complex healthcare challenges and accelerate the delivery of new therapies to patients.
📋 Description
• Serve as the Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects and programs. • Provide regulatory oversight and strategic guidance to internal and external stakeholders. • 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.
🎯 Requirements
• Bachelor'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.
🏖️ Benefits
• Professional development opportunities
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