Senior Manager/Associate Director, International Regulatory Affairs

BioMarin is seeking a highly motivated and energetic Senior Manager/Associate Director of International Regulatory Affairs to develop and execute regulatory submissions for BioMarin products in Japan. This role involves interfacing with the Japanese regulatory authorities, ensuring compliance with Japanese regulations, and providing strategic advice to support clinical development in Japan. The position is based in the Tokyo office.

Requirements

• Develop Japanese Regulatory filing strategies and identify risks.
• Ensure all submissions are prepared in accordance with Japanese regulations.
• Interface with Japanese regulatory authorities.
• Evaluate new and emerging regulations.
• Fluent in Japanese and English.
• Bachelor of science degree in life science.