Regulatory Affairs Manager

This is an exciting opportunity to join ICON

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

Benefits of Working in ICON :

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

ICON is an equal opportunity employer, including disability/veteran, and committed to providing a workplace free of discrimination and harassment.