Regulatory Technician
- Sao Paulo
- ICON Full Service & Corporate Support
- Regulatory Affairs
- Hybrid
TA Business Partner
- Full Service Division
About the role
Hybrid role
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.
As a Regulatory Technician at ICON, you will provide critical operational support to regulatory teams by preparing, organising, and maintain documentation required for global regulatory submissions.
What You Will Do:
You will take responsibility for regulatory affairs deliverables, applying your skills to ensure quality and efficiency.
Key responsibilities include:
- Preparing, formatting, and compiling regulatory documents and submission components according to established templates and standards.
- Maintaining regulatory trackers, databases, and filing systems to ensure documents are current, accurate, and inspection-ready.
- Supporting the coordination of regulatory submissions by gathering required information from cross-functional teams.
- Performing quality checks on documents for completeness, consistency, and adherence to style and formatting requirements.
- Assisting with the management of correspondence and documentation related to health authority interactions.
- Contributing to continuous improvement of regulatory operations processes, tools, and templates.
Your Profile:
You will bring relevant regulatory affairs experience, along with the following qualifications and skills.
Required qualifications and experience:
- Bachelor's degree in life sciences, pharmacy, documentation management, or a related field, or equivalent experience.
- Initial experience in regulatory affairs, clinical research, or a documentation-focused role is preferred.
- Strong attention to detail and organisational skills, with the ability to manage multiple documents and timelines.
- Good written and verbal communication skills, with a disciplined approach to formatting and compliance.
- Comfort working with document management systems, trackers, and standard office software.
- Proactive, collaborative mindset with a willingness to learn regulatory processes and guidelines.
- Willingness to travel as required (approximately 5%)
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. Learn more about Our Culture at ICON
Day in the life
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. I
Similar jobs at ICON
Salary
Location
India, Chennai
Department
Clinical Trial Management
Location
Bangalore
Chennai
Bengaluru
Remote Working
Hybrid
Business Area
ICON Full Service & Corporate Support
Job Categories
Regulatory Document Management
Job Type
Permanent
Description
We are currently seeking a TMF Lead to join our diverse and dynamic team. As a TMF Lead at ICON, you will be responsible for overseeing the Trial Master File (TMF) management processes, ensuring compl
Reference
JR146282
Expiry date
01/01/0001
Author
Swathy AnandanAuthor
Swathy AnandanSalary
Location
India, Chennai
Department
Clinical Trial Management
Location
Chennai
Remote Working
Hybrid
Business Area
ICON Full Service & Corporate Support
Job Categories
Regulatory Document Management
Job Type
Permanent
Description
We are currently seeking a Manager, TMF Operations to join our diverse and dynamic team. As a Manager of TMF Operations at ICON, you will oversee the management, maintenance, and compliance of the Tri
Reference
JR143093
Expiry date
01/01/0001
Author
Swathy AnandanAuthor
Swathy AnandanSalary
Location
US, Blue Bell (ICON)
Department
Full Service - Development & Commercialisation Solutions
Location
Blue Bell
Rochester
Remote Working
Remote or Office
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug / Device Regulatory Affairs
Job Type
Permanent
Description
We are currently seeking a Director, Medical & Scientific Affairs to join our diverse and dynamic Medical Imaging team. As a Director, Medical & Scientific Affairs at ICON, you will oversee all aspect
Reference
JR153716
Expiry date
01/01/0001
Author
Muna NelkeAuthor
Muna NelkeSalary
Location
US, Blue Bell (ICON)
Location
Blue Bell
Remote Working
Remote
Business Area
ICON Strategic Solutions (FSP)
Job Categories
Drug / Device Regulatory Affairs
Job Type
Temporary Employee
Description
As a Senior Manager, Regulatory Strategy at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapi
Reference
JR152975
Expiry date
01/01/0001
Author
Jonathan HolmesAuthor
Jonathan HolmesSalary
Location
US, Raleigh, NC
Location
Raleigh
Remote Working
Remote or Office
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug / Device Regulatory Affairs
Job Type
Permanent
Description
As a Senior Manager, Regulatory Affairs at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapie
Reference
JR152742
Expiry date
01/01/0001
Author
Sasha BrownAuthor
Sasha BrownSalary
Location
India, Chennai
Department
Clinical Trial Management
Location
Chennai
Remote Working
Hybrid
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
JR146301
Expiry date
01/01/0001