JUMP TO CONTENT

Regulatory Technician

  1. Warsaw
JR133431
  1. ICON Full Service & Corporate Support
  2. Regulatory Affairs
  3. Office Based

About the role

Regulatory Technician

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Regulatory Technician

As a Regulatory Technician you will be collaborating with key stakeholders to manage and complete data entry and document upload to and monitoring of Clinical Trial Regulatory systems/portals according to study specifics, ICON policies, procedures, applicable regulations and the principles of ICH-GCP with in line with contractual agreement. You will also support regulatory submissions and deliverables to meet department and project goals.

Duties and Responsibilities
• Recognize, exemplify and adhere to ICON's values which centre around our commitment to People, Clients and Performance
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
• Ensure Regulatory deliverables are performed in accordance with all relevant regulations, guidelines, policies and procedures within contractual timelines and budget
• Knowledge of ICON’s SOPs/WIs, ICH, GCP, appropriate regulations and guidance
• Knowledge of ICON systems applicable to role
• Proficient in using applicable business applications
• Successfully complete internal/external training for applicable Clinical Trial Regulatory system/portal to complete Regulatory submissions
• Standard expertise of applicable Clinical Trial Regulatory system/portal
• Proactively identify and mitigate risks through Regulatory Authority helpdesks or internal sources, regarding data/document management and upload to Clinical Trial Regulatory systems/portals and liaise with internal/external stakeholders to resolve
• Actively maintain applicable study-level account access for assigned projects for Clinical Trial Regulatory systems/portals to maintain compliance and confidentiality
• Collaborate with key stakeholders to manage and perform data entry and document upload to required country/regional Clinical Trial Regulatory systems/portals using the data and documents provided by project team
• Monitor Clinical Trial Regulatory systems/portals for notices and alerts and notifying applicable stakeholders of activities for their action and subsequent follow up
• Create files documenting submissions completed through Regulatory systems/portals, conclusions, decisions and any other communication provided via Regulatory systems/portals
• Perform Quality Control review in accordance with applicable process
• Maintain agreed timelines
• Support other Regulatory deliverables under the direction of leadership, as required
• Ensure project-specific training is completed on time, as applicable
• Travel (approximately 5%) domestic and /or international

Read and Write fluent English.

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply

List #1

Day in the life

Vaccination vial
The Role of Regulatory Affairs in Clinical Research

Teaser label

Industry

Content type

Blogs

Publish date

01/18/2024

Summary

Introduction to Regulatory Affairs in Clinical Research Regulatory affairs play a pivotal role in ensuring the safety, efficacy, and quality of pharmaceutical products and medical devices. In the

Teaser label

Explore the pivotal role of regulatory affairs in clinical research with our insightful blog.

Read more
View all

Similar jobs at ICON

Senior Manager, CMC strategy - Homebased in UK, Poland, Spain or Germany

Salary

Location

Europe

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Any EMEA Location

Remote Working

Home-Based

Area of interest

Europe ICON Full Service & Corporate Support Talent Acquisition

Business Area

ICON Strategic Solutions

Job Categories

Regulatory Affairs

Job Type

Permanent

Description

Senior Manager, Regulatory Strategy (CMC strategy) - Homebased in UK, Poland, Spain or GermanyAs a Senior Manager, Regulatory Strategy (CMC strategy) you will be joining the world’s largest & most com

Reference

2025-121717

Expiry date

01/01/0001

Patrick Hale

Author

Patrick Hale
Read more Shortlist Save this role
Senior Regulatory Affairs Specialist (CMC author) - 1-year Fixed term contract

Salary

Location

London, Poland, Spain, Germany

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Germany

Poland

Spain

London

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Regulatory Affairs

Job Type

Permanent

Description

Senior Regulatory Affairs Specialist (CMC author) - Homebased in UK, Poland, Spain or Germany (fixed term contract 1 year) As a Senior Regulatory Affairs Specialist (CMC) you will be joining the world

Reference

2025-121648

Expiry date

01/01/0001

Patrick Hale

Author

Patrick Hale
Read more Shortlist Save this role
Senior TMF Specialist

Salary

Location

India, Chennai

Department

Clinical Trial Management

Location

Chennai

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Regulatory Document Management

Job Type

Permanent

Description

We are currently seeking a Senior TMF Specialist to join our diverse and dynamic team. As a Senior TMF Specialist at ICON, you will play a pivotal role in managing the Trial Master File (TMF) for clin

Reference

JR132671

Expiry date

01/01/0001

Amrutha Saidala Read more Shortlist Save this role
Clinical Trial Documentation Specialist (Poland, Warsaw)

Salary

Location

Poland, Warsaw

Department

Full Service - Corporate Support

Location

Warsaw

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Regulatory Document Management

Job Type

Permanent

Description

We are currently seeking a Clinical Trial Documentation Specialist (TMF Specialist) to join our diverse and dynamic team. As the Specialist at ICON, you will play a vital role in becoming familiar wit

Reference

JR129275

Expiry date

01/01/0001

Jacek Jaworski Read more Shortlist Save this role
Regulatory Project Manager - East Coast

Salary

Location

United States

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

United States

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Regulatory Affairs

Job Type

Permanent

Description

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us

Reference

2025-121707

Expiry date

01/01/0001

Kala Murphy

Author

Kala Murphy
Kala Murphy

Author

Kala Murphy
Read more Shortlist Save this role
Study Start Up Associate II

Salary

Location

Mexico City

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Mexico City

Remote Working

Office Based

Business Area

ICON Strategic Solutions

Job Categories

Regulatory Affairs

Job Type

Permanent

Description

The  Study Start-Up Associate performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in accord

Reference

2025-121424

Expiry date

01/01/0001

Rita Villavicencio Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above