Remote NL Regulatory & Site Activation Specialist

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

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.