# Regulatory Affairs Professional

**Company**: IQVIA
**Location**: Lisbon, Portugal
**Experience**: senior
**Job type**: full-time
**Category**: Policy & Public Affairs
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Lisbon-Portugal/Regulatory-Affairs-Specialist--IQVIA-Biotech_R1578241?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_b5ed96e5-abb

## Description

We are seeking a Regulatory Affairs professional to join our IQVIA Biotech Regulatory Affairs team, supporting clinical research projects across Europe.

In this role, you will provide regulatory expertise and hands-on support throughout clinical development, with a particular focus on EU Clinical Trials Regulation (EU CTR) submissions. You will work as part of a global, project-based team supporting primarily drug development programs, including chemical entities and biologics.

This is a great opportunity for someone who already has practical EU CTR submission experience and is ready to take ownership of regulatory activities within assigned projects.

**Responsibilities**

- Take regulatory responsibility for assigned clinical research projects, providing regulatory guidance and operational support to project teams.

- Independently prepare and complete EU CTR submissions, ensuring regulatory requirements and timelines are met.

- Interpret and apply relevant regulations, guidelines and regulatory agency requirements.

- Review protocols, reports and other clinical and scientific documentation for regulatory compliance.

- Support regulatory authority interactions, communications and submissions.

- Compile, maintain and manage regulatory documentation required for assigned clinical research projects.

- Provide regulatory input and guidance to cross-functional project teams.

- Support primarily drug development programs, including chemical entities and biologics.

- Contribute to broader Regulatory Affairs activities and cross-functional initiatives as required.

**Requirements**

- Bachelor’s degree, ideally in a scientific or related discipline, or an equivalent combination of education and relevant experience.

- At least 3 years of relevant professional experience within Regulatory Affairs, clinical research or a closely related area.

- Hands-on EU CTR submission experience, with the ability to manage and complete submissions independently.

- Good understanding of European clinical trial regulatory requirements and Good Clinical Practice.

- Experience reviewing and working with clinical and regulatory documentation.

- Strong analytical skills and the ability to interpret complex regulatory information.

- Excellent written and verbal communication skills.

- Strong attention to detail and the ability to work effectively within cross-functional and international project teams.

**Nice to Have**

- Regulatory experience outside Europe, for example North America.

- Experience working with biologics.

- Previous CRO and/or pharmaceutical/biotech industry experience.

- Knowledge of medical-device regulatory requirements.

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## Skills

### Required
- EU CTR submissions
- regulatory affairs
- clinical research
- Good Clinical Practice
- regulatory compliance

### Nice to have
- regulatory experience outside Europe
- biologics
- CRO experience
- medical-device regulatory requirements

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Lisbon-Portugal/Regulatory-Affairs-Specialist--IQVIA-Biotech_R1578241?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)