Regulatory Affairs Specialist

ICON

Seoul, South Korea
Regulatory submission processes
Label review and translation
Clinical trial documentation
As a Regulatory Affairs Specialist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies

Job Summary

  • As a Regulatory Affairs Specialist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
  • ICON offers a range of benefits focused on well-being and work-life balance, including various annual leave entitlements, health insurance options, retirement planning, and a global employee assistance program.
  • ICON is committed to providing an inclusive and accessible environment, ensuring equal consideration for employment without discrimination and offering reasonable accommodations for applicants with disabilities.

Matching Summary

As a Regulatory Affairs Specialist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

Skills & Requirements

Must-have

  • Regulatory submission processes
  • Label review and translation
  • Clinical trial documentation
  • Regulatory intelligence activities
  • Cross-functional collaboration

Nice-to-have

  • Strong attention to detail
  • Excellent communication skills
  • Business development facilitation
  • Inclusive and diverse work environment

Key Requirements

  • Bachelor's degree in scientific or healthcare field
  • 2-3 years regulatory affairs experience
  • Proficiency with CT/IND, MAA/NA submissions
  • Experience with DSUR, PSUR, and renewals

Work Rights

Not specified

Tailored Resume

Cover Letter