This leadership role will be responsible for Japan Regulatory strategy for all products and management and leadership of Japan Regulatory staff
Job Summary
This leadership role will be responsible for Japan Regulatory strategy for all products and management and leadership of Japan Regulatory staff.
The role serves as the primary contact to all Regulatory Authorities in Japan, identifying and assessing regulatory risks and providing regulatory guidance.
Biogen fosters an environment where individual contributions make a significant impact, working together to deliver life-changing medicines.
Matching Summary
This leadership role will be responsible for Japan Regulatory strategy for all products and management and leadership of Japan Regulatory staff.
Skills & Requirements
Must-have
Japan regulatory strategy
Regulatory filings and inspections
Primary contact to Regulatory Authorities
Preparation of clear and effective submissions
Experience with PMDA
Nice-to-have
Pioneering spirit
Commitment to excellence
Culture of inclusion and belonging
Strategic thinker
Initiate new ideas
Key Requirements
Minimum 10 years strategic regulatory leadership
Minimum 5 years people management experience
Preferably 5 years clinical development and planning experience
Strong knowledge of applicable Japan regulations
Bilingual English and Japanese
Experience in preparation of major regulatory submissions