Über diese Regulatory Affairs Admin Assistant Stelle bei ICON plc
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
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)
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply
