Regulatory Affairs Associate

Regulatory Affairs-Office Based-South Korea

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.

We are currently seeking a Clinical Trial Administrator to join our diverse and dynamic team. As a Clinical Trial Administrator at ICON, you will play a pivotal role in assisting with the design and analysis of clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies.

What you will be doing

• 안전관리자료, 해외사용현황, 품질, 표시자재, 수입실적, 허가증 – 갱신 식약처 제출 업무
• SMF (Site Master File) - 해외제조소 (원료 수입처) 등록 관련 업무
• OTC (일반 의약품) 품목 신고
• DMF (Drug Master File) - 원료 의약품 등록

Your profile

• Bachelor's degree in a scientific or healthcare-related field.

• Prior experience or strong interest in clinical research.

• Knowledge of clinical trial processes, regulations, and guidelines.

• Excellent organizational and communication skills.

• Ability to work collaboratively in a fast-paced environment with attention to detail.

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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