Head of Regulatory Affairs

Job Overview

•This leadership role, Director Regulatory Affairs Japan, will be a key member of the Japan R&D Development team; Implementation and maintenance of Japan regulatory processes, systems, and operations in Japan; This role will be responsible for Japan Regulatory strategy for all products. Responsible for management and leadership of Japan Regulatory staff.

Collaborates and partners with the heads of Global Regulatory function heads at headquarters to:

•Provide Japan input into global regulatory strategy ensuring efficient global product development and global regulatory solutions and services;

•Implementation of global regulatory strategy in Japan; Responsible for translating strategic business objectives into action.

•Provide a key point of contact between Development and Commercial in Japan

•Engages with colleagues across Japan site and Global regulatory to support Regulatory filings and inspections.

Principal Accountabilities

1. Serve as primary contact to all Regulatory Authorities in Japan; Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks. Provide regulatory guidance to key stakeholders throughout the research and development process.

2. Maintain positive collaborations cross functionally with such business groups as Global Clinical Operations, Global Commercial Strategy, Legal, SABR, PO&T, Medical Affairs

3. Provide direction and mentorship to Regulatory staff in Japan; Develop and maintain highly capable and dedicated regulatory staff. Guide team in carrying out responsibilities.

4. Interface regularly with the Commercial organization to manage and focus on life cycle and pipeline products.

5.Direct the Japan organization in preparation of clear and effective submissions

6. Monitor and analyze appropriate regulatory agency activities in areas of interest to the company.

Minimum Experience Requirements

•Ideal candidate will have a minimum of 10 years strategic regulatory leadership, project and planning experience, including 5 years people management experience.

•Preferably clinical development and planning experience 5 years, Strong knowledge of applicable Japan regulations.

•Must be bilingual – English and Japanese

•Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.

•Experience in interfacing with relevant regulatory authorities (PMDA).

•Foster effective, positive interactions with regulatory agencies, and corporate partners.

•Ability to lead and influence project teams, committees, etc. to attain group goals.

•Demonstrate excellent leadership and communication skills.

•Strategic thinker; ability to think globally and initiate new ideas;

Minimum Education Requirements

•BA/BS/University degree required, Preferably PhD. degree required, Life/Health Sciences preferred

 

Job Level: Management