Head of RA/QA

＊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)＊

Executive Director, Regulatory Affairs (Head of RA/QA)

The Executive Director of Regulatory Affairs is an extraordinary opportunity to provide strategic and tactical leadership for the regulatory affairs organization to further drive the safe and successful adoption of products in the Japan market.

Role & Responsibility:

Primary Function of Position:

• Develop, manage and implement regulatory strategy to maintain existing product lines or support entry into new markets upon creation of new products

• Develop and implement reimbursement strategy to obtain adequate level of health insurance policy in timely manner

• Oversee and manage communications with government / regulatory agencies and KOLs on a global basis

• Maintain and manage cooperative relationship with global regulatory, marketing and production teams to pursue Japan regulatory, quality and safety programs.

• Grow, develop and manage team to interface and support all regulatory requirements of the company with the appropriate external organizations

• On a regular basis, interact with company leaders to ensure that business objectives are aligned with regulatory and clinical objectives

Roles and Responsibilities:

• Proactively interpret regulatory guidelines and regulations, anticipate concerns, educate and integrate requirements into development programs

• Manage Japan RA, safety and quality function to develop and implement Japan regulatory strategy

• Establish and maintain relationship with government agencies, external regulatory related organizations and KOLs to carry out company RA strategies

• Plan and manage the growth in RA, Safety and Quality management functions

• Develop and maintain good working relationship with the company’s global teams and proactively participate in the company’s effort in global regulatory activities