# Regulatory and Start-Up Specialist

**Company**: IQVIA
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Amsterdam-Netherlands/Regulatory-and-Start-Up-Specialist---Netherlands_R1547012?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_0e7b7c8b-920

## Description

At IQVIA, our Clinical Functional Service Partnership (CFSP) models offer the best of both worlds: the opportunity to work as an integrated member of a leading sponsor's team while benefiting from the global expertise, career development and support of IQVIA.

As a Regulatory and Start-Up Specialist, you will play a critical role in bringing clinical trials to life. Working within a sponsor-dedicated environment, you will manage site identification, regulatory submissions, ethics approvals and site activation activities that help studies start faster and accelerate patient access to innovative treatments.

**Key Responsibilities**

- Serve as the primary point of contact for investigative sites, Site Activation Managers, Project Managers and internal stakeholders.

- Execute site identification, feasibility assessment, and site activation activities for assigned clinical studies.

- Prepare, review, and distribute regulatory documentation to ensure completeness, accuracy, and compliance.

- Track and manage submission, approval, and execution of essential documents.

- Review, negotiate, and manage site regulatory documents, contracts, and associated start-up deliverables.

- 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.

- Experience in clinical trial regulatory affairs, site start-up, site activation, or related clinical research functions.

- Strong understanding of local and international regulatory requirements, GCP, and clinical research processes.

- Experience managing regulatory documentation, contracts, and start-up deliverables.

- Excellent communication, negotiation, and problem-solving capabilities.

- Fluency in Dutch with strong English communication skills.

## Skills

### Required
- Life Sciences
- clinical trial regulatory affairs
- site start-up
- site activation
- GCP
- Dutch
- English

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Amsterdam-Netherlands/Regulatory-and-Start-Up-Specialist---Netherlands_R1547012?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)