Regulatory Affairs Manager

Regulatory Affairs Manager, Korea, Home worker

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.

Regulatory Affairs Manager

Seoul, Korea

Are you ready to be a part of a successful study delivery team? ICON’s award-winning study execution capabilities have led to the approval of 18 of the world’s top 20 best-selling drugs. Make your experience count for the benefit of patients worldwide. www.iconplc.com

Job Description: 

・Represent Regulatory Affairs function on project teams and client meetings to provide

・Provide Regulatory guidance to project teams and/or clients as appropriate

・Consultations with regard to regulatory aspects of protocols and clinical development programs

・Preparation of regulatory submissions including full INDs, NDAs, supplements and strategic activities

・Preparation and submission of safety reports to health authorities

・Review and sign-off authorization of regulatory submissions as determined by Senior Director

・Primary liaison with FDA and other agencies

・Supervise and mentor Regulatory Affairs Associates

・Client liaison

・Tracking of resources, timelines and budgets

・Involvement with staff development (hiring, supervision, performance appraisals and mentoring)

・Preparation of bids and proposals

Qualifications:

・7+ years of proven experience as RA professional

・ Bachelor’s Degree or higher graduate degree from the Medical/science background and/or discipline

・Able to prepare for clinical development plan and its registration strategy for drugs

・Able to develop briefing documents for PMDA consultation

・Know Korea regulation and various guidelines to be required clinical development and its registration for drugs

・Tough negotiator with competent health authorities

・Experience of CTN, writing CSR and CTD, PMDA inspection

・ Excellent written and spoken English and fluency in Korean

・Competent computer skills

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.

ICON, including subsidiaries, 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, colour, 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