Regulatory Technician
- Warsaw
- ICON Full Service & Corporate Support
- Regulatory Affairs
- Office Based
TA Business Partner
- Full Service Division
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
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
Day in the life
.png)
Teaser label
IndustryContent type
BlogsPublish 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
Similar jobs at ICON
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
Author
Patrick HaleAuthor
Patrick HaleSalary
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
Author
Patrick HaleAuthor
Patrick HaleSalary
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
Author
Amrutha SaidalaAuthor
Amrutha SaidalaSalary
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
Author
Jacek JaworskiAuthor
Jacek JaworskiSalary
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
Author
Kala MurphyAuthor
Kala MurphySalary
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
Author
Rita VillavicencioAuthor
Rita Villavicencio