Japan_Development pharmaceutical affairs
Core
Regulatory affairs and quality assurance work supporting the product lifecycle of biopharmaceuticals, including drug applications, CTD/FD document creation, and coordination with authorities and manufacturers.
Role type
Regulatory Affairs Specialist (Biopharmaceuticals)
Builds
Regulatory submissions and quality assurance documentation for biosimilars and innovative biopharmaceuticals
Domain
Biopharmaceuticals / Regulatory Affairs
Required skills
Pharmaceutical application preparation, CTD/FD document creation, Regulatory authority communication, Quality assurance coordination, CMC regulatory support, Manufacturing process alignment
Preferred skills
Experience in advanced pharmaceutical markets, Knowledge of global regulatory requirements
Technologies
CTD, FD, Regulatory submission systems