Regulatory Affairs Admin Assistant - Office-based
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 Affairs Admin Assistant at ICON, you will support regulatory operations, product registration activities, and lifecycle management processes. This role will be responsible for coordinating regulatory submissions, maintaining compliance documentation, monitoring application progress, and supporting post-approval regulatory activities.
What You Will Do
Your role will involve delivering regulatory affairs work to a high standard, working closely with your team and stakeholders.
Key Responsibilities Include
- Manage regulatory document archiving, retrieval, and records maintenance activities.
- Process payment requests and coordinate regulatory application fees with internal stakeholders.
- Prepare, compile, and submit regulatory applications and supporting documentation to health authorities.
- Monitor regulatory application statuses and proactively follow up on pending approvals and submissions.
- Support regulatory document requests related to business opportunities, tenders, and formulary inclusion activities.
- Coordinate notarization and certification of regulatory documents when required.
- Track and maintain incoming compliance documents, including certificates, licenses, authorizations, and quality-related documentation.
- Maintain regulatory databases, document repositories, and product master records to ensure accuracy and compliance.
- Upload, organize, and maintain regulatory documentation within electronic document management systems.
- Perform regulatory data updates and support ongoing records maintenance activities.
- Support Product Lifecycle Management activities, including post-approval changes, minor variations, renewals, and maintenance of product registrations.
- Ensure regulatory records are complete, current, and inspection-ready.
- Collaborate cross-functionally to support regulatory compliance and product registration objectives.
Your Profile
You will bring relevant regulatory affairs experience, along with the following qualifications and skills.
Required Qualifications And Experience
- Bachelor's degree in a relevant scientific discipline or healthcare-related field
- Minimum of 1 year of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Understanding of regulatory submissions, product registrations, renewals, and post-approval maintenance activities.
- Strong attention to detail and excellent communication skills.
- Willingness to work on Office-based setup (4x a week RTO at client office in BGC)
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
