RA/QA/MA Head (4549)

Jobs

Description

＊This role requires native level Japanese and Business English＊

＊日本語がネイティブレベルで英語が流暢に会話ができる方(両方必須)＊

Role & Responsibility:

Manage a large team RA/QA and Medical Affairs
Collaborate with Regulatory member both in Local and Global, and with all of member related to New product introduction process
Support local clinical studies for registration purpose as well as for higher clinical recognition
Support to obtain registration approval/certification
Collaborate with pharmaceutical industry for companion diagnostics for novel drugs
As Head of Medical, Quality and Regulatory Affairs, collaborate with our Global Headquarters and cooperate with domestic Key Opinion Leaders (KOLs) to maximize the clinical value of our innovative new products in Japan. We will establish a system and carry out domestic clinical research as needed.
In addition, you will be responsible for a series of processes for consulting and negotiating with the authorities and obtaining regulatory approval and insurance coverage.
As for products after launch, the main task is to work with teachers of academic societies and on-site clinicians to educate the significance of measurement in on-site medical care and to spread it widely.
In addition, you will be responsible for ensuring the quality of a wide range of products in cooperation with our Global headquarters and relevant authorities.

Required experience

Japanese level: Native
English level: Business
People Management experience
One of the following:
- Faculty status in the medical school and / or important role in the medical / academic community
- Work experience with MHLW, general agencies and other authorities
- Work experience at a pharmaceutical / medical device company

Ideal knowledge and skills / qualifications

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