This leadership role will be a key member of the Japan R&D Development team, responsible for Japan Regulatory strategy for all products and management of Japan Regulatory staff
Job Summary
This leadership role will be a key member of the Japan R&D Development team, responsible for Japan Regulatory strategy for all products and management of Japan Regulatory staff.
The role involves providing Japan input into global regulatory strategy, ensuring efficient global product development and implementing global regulatory strategy in Japan.
Biogen fosters an environment where individual contributions make a significant impact, with unparalleled opportunities for learning, growth, and expanding skills to deliver life-changing medicines.
Matching Summary
This leadership role will be a key member of the Japan R&D Development team, responsible for Japan Regulatory strategy for all products and management of Japan Regulatory staff.
Skills & Requirements
Must-have
Japan regulatory strategy
Regulatory filings and inspections
Interface with PMDA
Bilingual English and Japanese
Nice-to-have
Pioneering spirit
Commitment to excellence
Life-changing medicines
Culture of inclusion and belonging
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
Experience in preparation of major regulatory submissions
Experience interfacing with relevant regulatory authorities (PMDA)