Regulatory Affairs Manager

Position Name : Regulatory Affairs Manager

Location : Tokyo, Japan

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

・Perform other duties as assigned.

Qualification :

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

・Able to develop briefing documents for PMDA consultation

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

・Tough negotiator with competent authorities, PMDA and occasionally MHLW.

・English skills to have efficient communication by e-mails, teleconference and F2F meeting overseas.

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

・Over 5 years of clinical development as PM or COM

・Over 5 years of regulatory affairs including a manager position

Benefits of Working in ICON

You will be working as a Leader with a great team of smart and energetic people. ICON will offer you a very competitive management benefits package. This does vary 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.

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