Head of Regulatory Affairs

Tokyo - Japan

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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.

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

Why Biogen

We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver life-changing medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an E-Verify Employer in the United States.

Required Experience:

Director

Job OverviewThis 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. Respo...