Regulatory and Start Up Specialist - Netherlands

IQVIA LLC; Amsterdam; Hybrid; EUR 60,000 - 85,000; Full time

Job summary

IQVIA LLC seeks an RSU Specialist to join the Site Activation team in the Netherlands. This home-based role requires Dutch fluency and deep knowledge of local regulatory requirements to ensure timely site activation in EU markets.

The candidate will manage regulatory submissions, ethics processes, CTAs, and contract negotiations while coordinating with SAMs and project teams to uphold timelines and quality standards.

Qualifications

• Bachelor's Degree in Life Sciences or related field.
• 3.5–5 years' experience in clinical research with site activation.
• Experience with regulatory submissions, CTAs and negotiations.
• Knowledge of Belgian and international clinical trial regulations.
• Dutch language fluency and strong English communication.

Responsibilities

• Serve as the primary contact for investigative sites, SAMs, PMs and internal stakeholders.
• Coordinate and execute country-specific site activation and regulatory activities.
• Prepare, review, and distribute regulatory documentation for completeness and compliance.
• Track submissions including regulatory, ethics, ICFs, IP release, CTAs.
• Support contract negotiations and timelines; maintain records in systems.

Skills

Site Activation

Regulatory submissions

CTAs & negotiations

Start-up activities

Regulatory knowledge Belgium

Dutch fluency

English communication

Planning & organization

Stakeholder management

Education

Bachelor's Degree in Life Sciences or related field

Job description

RSU Specialist Level: Senior Associate Location: Netherlands (Home Based) About IQVIA IQVIA is a leading global provider of clinical research services, healthcare intelligence, and commercial insights to the life sciences industry. With more than 88,000 employees worldwide, we help accelerate the development and commercialization of innovative treatments that improve patient outcomes and population health. As a global leader in clinical development, we combine data, technology, scientific expertise, and operational excellence to help our customers navigate the complex healthcare landscape and bring new therapies to patients faster.

The Opportunity

We are seeking an experienced RSU Specialist to join our Site Activation team in Netherlands. This home-based position requires strong knowledge of local regulatory requirements, site activation processes, and contract negotiations. Fluency in Dutch is essential. In this role, you will act as the key point of contact for investigative sites, Site Activation Managers (SAMs), project teams, and other stakeholders, ensuring site activation activities are completed efficiently and in compliance with local regulations, SOPs, and project timelines.

Key Responsibilities

• Serve as the primary point of contact for investigative sites, Site Activation Managers, Project Managers, and internal stakeholders.
• Coordinate and execute country-specific site activation and regulatory activities.
• Prepare, review, and distribute regulatory documentation to ensure completeness, accuracy, and compliance.
• Track and manage submission, approval, and execution of essential documents, including:
• Regulatory submissions
• Ethics Committee submissions
• Informed Consent Forms (ICFs)
• Investigator Pack (IP) release documentation
• Clinical Trial Agreements (CTAs)
• Support contract negotiation activities and timelines.
• Maintain accurate records within internal systems and tracking tools.
• Monitor project milestones and proactively identify risks and mitigation plans.
• Provide local regulatory expertise to project teams and Site Activation Managers.
• Perform quality reviews of site documentation.
• Review site performance metrics and contribute to continuous process improvement initiatives.
• Collaborate closely with sponsors and cross-functional teams to ensure successful study start-up and site activation delivery.

What We're Looking For

• Bachelor's Degree in Life Sciences or a related scientific discipline.
• Approximately 3.5 to 5 years' experience within clinical research.
• Strong experience in:
• Site Activation
• Regulatory submissions
• Clinical Trial Agreements (CTAs) and contract negotiations
• Clinical trial start-up activities
• Solid understanding of Belgian and international clinical trial regulations.
• Fluency in Dutch with strong English communication skills.
• Excellent planning, organization, and problem-solving abilities.
• Ability to manage multiple priorities and work effectively in a fast-paced environment.
• Strong stakeholder management and communication skills.

Why Join IQVIA?

• Home-based flexibility within Belgium.
• Opportunity to work on innovative and impactful clinical studies.
• Exposure to a wide range of therapeutic areas and sponsors.
• Global career development and advancement opportunities.
• Collaborative and inclusive culture focused on growth and continuous learning.
• Join a team dedicated to accelerating healthcare innovation and improving patient outcomes worldwide.

At IQVIA, we believe diversity, inclusion, and belonging are key to driving innovation. We are committed to creating an environment where every individual can bring their authentic self to work and contribute to improving healthcare for patients around the world. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.