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Regulatory Affairs Lead at IQVIA - ApplyBlast

Regulatory Affairs Lead

IQVIA

16 days ago

3.8 on Glassdoor

Belgrade, Serbia

Onsite

Full Time

Senior

0 applicants

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About this role

This role provides strategic regulatory expertise and leadership for clinical trial applications and lifecycle management, with a strong focus on EU Clinical Trials Regulation (CTR) submissions and Clinical Trials Information System (CTIS) management. The individual will act as a Regulatory Global Team Leader or Project Manager, guiding clients through EU submission strategies, RMS selection, and regulatory authority interactions. The position requires advanced knowledge and at least 8 years of relevant industry experience to ensure compliance and successful project execution.

Responsibilities

Lead preparation and submission of regulatory documentation for EU CTR and CTIS
Provide strategic regulatory advice and manage client relationships
Manage project timelines, budgets, and mentor junior colleagues

Skills

About IQVIA

iqvia.com

Headquarters

Durham, North Carolina, United States

Company Size

10001+ employees

Founded

2016

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IQVIA is a leading global provider of data, technology, and advanced analytics focused on transforming healthcare and life sciences. The company empowers organizations to accelerate innovation, enhance patient outcomes, and expedite the market introduction of new treatments through comprehensive healthcare analytics and real-world evidence. With a commitment to Human Data Science, IQVIA combines its extensive expertise with innovative technology to improve health outcomes worldwide.