At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
The role
Senior Regulatory Associate
Seoul, Korea (Hybrid role)
Duties will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs but may be in other related areas.
- As member of the Regulatory Submissions team, you will contribute to at least one of the following activities:
- Preparation, compilation and submission of CT /IND, MAA I NOA. Variations/ lifecycle submissions, DSUR, PSUR, renewals, agency briefing documentation
- Management and Implementation of label review, translation requirements, fee requirements etc. for regulatory submissions
- Input to the Reg Intel function
- Readability testing
- IMPD / IB Core Doc review, labelling review for CT
- May work either as part of Regulatory Submissions team or as part of a regulatory or cross-functional team depending on the size and nature of project
- May support business development activities
You will need:
- 1+ year of hands on experience in KFDA clinical trial related submissions and IRB submissions activities
- Experience in sequence building and document level publishing
- Knowledge of local regulatory requirements/guidelines and global standards and Korea HA/EC submission
- Bachelor’s Degree
- Good interpersonal communication skills
- Business English level both writing and speaking and native in Korean
- Competent computer skills
Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.
We offer competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and 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
