Senior Manager - Associate Director, Regulatory Affairs, Japan
BeOne Medicines Ltd
Japan, Japan
Japan regulatory strategies
Drug development lifecycle
Health authority interactions
The Associate Director, Regulatory Affairs, Japan will be responsible for developing, implementing, and advising on Japan regulatory strategies for development programs to secure and maintain market access for product(s) in line with Global and Japan business objectives
Job Summary
The Associate Director, Regulatory Affairs, Japan will be responsible for developing, implementing, and advising on Japan regulatory strategies for development programs to secure and maintain market access for product(s) in line with Global and Japan business objectives.
The incumbent will provide leadership and strategic regulatory oversight for designated projects ensuring that the latest requirements and standards are met.
BeOne offers a market competitive compensation package including performance-based annual bonus scheme, company shares, in-house and external learning and development opportunities, and a fantastic benefits program.
Matching Summary
The Associate Director, Regulatory Affairs, Japan will be responsible for developing, implementing, and advising on Japan regulatory strategies for development programs to secure and maintain market access for product(s) in line with Global and Japan business objectives.
Skills & Requirements
Must-have
Japan regulatory strategies
drug development lifecycle
Health Authority interactions
CTN, NDA, BLA submissions
ICH regulatory requirements
Nice-to-have
collaborative, supportive, inclusive, fun professionals
passionate interest in fighting cancer
bold ingenuity
driving excellence
Key Requirements
Minimum 10 years experience in biotechnical or pharmaceutical industry
Minimum 5 years experience in Regulatory capacity
Minimum 5 years experience on Japan development programs
Prior experience with small molecules and biologics
Excellent interpersonal, oral and written communication skills in Japanese and English