Senior Manager/Associate Director, International Regulatory Affairs
BioMarin Pharmaceutical Inc.Chiyoda, Japan • Maryland, United States • Central Java, Indonesia
Posted August 6, 2025
Full Time
About the Company
BioMarin Pharmaceutical Inc., founded in 1997, is a global biotechnology company dedicated to transforming lives through genetic discovery. The company specializes in developing targeted therapies that address the root cause of rare genetic diseases, with eight first or best-in-class treatments already commercialized and a pipeline of product candidates for broader genetic disorders. BioMarin's innovative approach combines science-driven research with a patient-centric focus, aiming to impact more lives through its cutting-edge solutions.
Job Description
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.
