JUMP TO CONTENT

Clinical Regulatory Specialist

055970_2

About the role

This vacancy has now expired. Please click here to view live vacancies.

Global Clinical Regulatory Specialist (Operations Lead, Regulatory) 

  

Location: Spain, Poland ideally, other EU Countries considered

 

 

ICON are currently looking for a Clinical Regulatory Specialist to join our Research Services Hub in EU. Working within this team, you will work with a team of professionals who provide strategic and operational expertise in the design and conduct of Post-Approval and commercialization programs for Pharmaceuticals, Biologics and Medical Devices. 

 

  

The Regulatory Specialist will work closely with the local German site contracts and ethics and regulatory teams in providing support in managing all regulatory aspects of the assigned projects in accordance with protocol specifications, applicable guidelines, regulatory requirements and SOPS.  

 

Responsibilities:

 

In the role of Regulatory Specialist, you will be: 

  • Responsible for oversight of regulatory and ethics submissions for assigned projects/countries (all regions)/sites, which may include completion of submissions or notificationsas required.

     

  • Responsible for oversight of studies start-up phase until SIV completion, ensuring that all start-up activities are performed within the defined timelines.

     

  • Responsible for providing advice and support to the project team for regulatory aspects of the clinical trials and late phase studies. 

     

  • Responsible for providing regulatory support as needed for drafting applicable study documents, including the protocol and informed consent form. 

     

  • Responsible for investigating proactively and capitalizing regulatory information collected throughout studies and maintain Regulatory database accordingly. 

     

  • Responsible for providing input and oversight for ongoing development and enhancement of systems used in the frame of Clinical Regulatory Affairs activities. 

     

  • Responsible for updating and maintaining regulatory information in the Study Management System and/or reporting mechanism, and for ensuring appropriate paper and electronic filing. 

     

  • Responsible for liaising with other departments on requirements for regulatory and ethics submissions. 

     

  • Participating in the improvement of the Quality Assurance System.

     

You will have: 


  • Education to degree level

     

  • Strong knowledge of ICH/GCP guidelines or other relevant guidelines (GEP, GPP or local requirements)

     

  • Ideally EU / Global experience
  • Proficiency with computer systems

     

  • Strong verbal and written communication skills

     

  • Strong organizational, time management, interpersonal skills.

     

  • Ability to work both independently and in a team environment.

     

  • Fluent in English and German will be advantageous.

     

Next Steps:

 

  

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

 

  

#LI-EJ1



 
List #1

Day in the life

Blood cancer cells
Blood Cancer Day - Raising Awareness and Driving Change

Teaser label

Industry

Content type

Blogs

Publish date

05/29/2025

Summary

Blood Cancer Day Blood Cancer Day is a powerful reminder of the millions of individuals and families whose lives are affected by hematological malignancies every year. These diseases are complex,

Teaser label

Learn how clinical research is transforming the future for those affected by hematological cancers.

Read more
Silver ribbon
Recognising World Schizophrenia Day through Research and Compassion

Teaser label

Industry

Content type

Blogs

Publish date

05/22/2025

Summary

World Schizophrenia Awareness Day 2025 Every year on 24 May, World Schizophrenia Awareness Day offers a vital opportunity to raise awareness, dismantle stigma, and celebrate the strength of individ

Teaser label

Explore how ICON is advancing schizophrenia research and addressing stigma through clinical innovation.

Read more
Ovarian cancer knot being held in woman's hands
Standing Strong on Ovarian Cancer Day

Teaser label

Inside ICON

Content type

Blogs

Publish date

05/08/2025

Summary

Standing Strong on Ovarian Cancer Day:    ICON's Commitment to Advancing Care Ovarian cancer remains one of the most challenging gynaecologic malignancies, both in terms of detection and treatmen

Teaser label

Martin Lachs, VP, Oncology Project Management at ICON discusses ICON’s role in advancing ovarian cancer research.

Read more
View all

Similar jobs at ICON

Tech Reporting Specialist II

Salary

Location

Turkey, Ankara

Location

Ankara

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Data Management

Job Type

Permanent

Description

We are currently seeking a Tech Reporting Specialist II to join our diverse and dynamic team. As a Tech Reporting Specialist II at ICON, you will play a crucial role in enhancing our reporting capabil

Reference

JR130613

Expiry date

01/01/0001

Tereza Svobodova Read more Shortlist Save this role
Supervisor, Home Health Supplies (Floor Supervisor)

Salary

Location

US, Blue Bell (ICON)

Location

Blue Bell

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Research In-Home Services

Job Type

Permanent

Description

Supervisor, Home Health Supplies (Floor Supervisor)Onsite - Blue Bell, PAWe are currently seeking a Supervisor, Home Health Supplies (Floor Supervisor) to join our diverse and dynamic team. As a Super

Reference

JR129631

Expiry date

01/01/0001

Sasha Brown

Author

Sasha Brown
Sasha Brown

Author

Sasha Brown
Read more Shortlist Save this role
Clinical Trial Recruitment Representative - PRN

Salary

Location

US, Salt Lake City (PRA)

Department

Full Service - Early Clinical and Bioanalytical Solutions

Location

Salt Lake City

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Study Start Up

Job Type

Temporary Employee

Description

We are currently seeking a Clinical Trial Recruitment Representative to join our diverse and dynamic team at ICON at our Salt Lake City UT site. Location: On-Site Salt Lake City UTJob Type: PRN/As Nee

Reference

JR129814

Expiry date

01/01/0001

Stephanie Curran Read more Shortlist Save this role
Intern - IHCRA

Salary

Location

Czech Republic, Prague

Department

Clinical Monitoring

Location

Prague

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Intern

Job Type

Intern

Description

We are currently seeking an Intern to join our diverse and dynamic team. As an Intern at ICON, you will have the opportunity to gain hands-on experience in a professional environment, supporting vario

Reference

JR131143

Expiry date

01/01/0001

Lauren Pritchett Read more Shortlist Save this role
Program Manager, Labs

Salary

Location

US, Blue Bell (ICON)

Department

Full Service - Development & Commercialisation Solutions

Full Service - Global Business Services

Location

New York

Blue Bell

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Project/ Program Management

Job Type

Permanent

Description

Program Manager, Labs – Blue Bell PA, Farmingdale NY- Hybrid.    Assist the team of PMs in issue resolution / escalation during the lifetime of all trials  • Understand your Project Managers’ performa

Reference

JR130137

Expiry date

01/01/0001

Frank Lampart

Author

Frank Lampart
Read more Shortlist Save this role
Surgical Science Liaison (Neurosurgery)

Salary

Location

United States

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

United States

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Other

Job Type

Permanent

Description

As a Surgical Science Liaison (Neurosurgery) – Part-time/Contract, you will join the world’s largest and most comprehensive clinical research organization, driven by healthcare intelligence.

Reference

2025-119361

Expiry date

01/01/0001

Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above