Regulatory Affairs Manager

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

In comparison with our competitor's and pharmaceutical companies, we provide more flexible and reasonable working platforms for coaching and educating new comer's to be highly respected professionals in our industry. ICON also provides successful candidates with an excellent employment package and benefits adapted to the current job market. We are more like an extended family with consideration of staff as individuals allowing a work-life balance.

Additionally, we have cutting edge technology that will allow you to analyze study specific processes, audit reports, and governance to quality system checks and ensure compliance.

What's Next
Following your application, if you have the necessary skills and experience for this job you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment
We care about our people, since 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
We are an equal opportunity employer and value diversity at our company We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status