Associate Clinical Trials Regulatory Manager, EMEA

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IQVIA

WebsiteLinkedInAll Job Openings

10,000+ employees

⚕️ Healthcare Insurance

🧬 Biotechnology

🤖 Artificial Intelligence

💰 $1G Post-IPO Debt on 2023-05

Healthcare Insurance • Biotechnology • Artificial Intelligence

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

• 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 IMPDs and clinical trial justifications

🎯 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 • Advanced knowledge of clinical trial regulations and regulatory submission processes • Strong analytical and problem-solving skills

🏖️ Benefits

• Regulatory support and oversight • Working with global programs • Support business development activities by providing regulatory expertise • Deliver regulatory training and presentations