【Alexion Japan】Clinical Scientist, Associate Director, R&D Division
Core
Lead clinical strategy and regulatory interactions for drug development programs in Japan, serving as the primary expert liaison between global clinical development and local regulatory authorities.
Role type
Senior IC clinical scientist (regulatory & strategy)
Builds
Clinical development programs, regulatory filings, and advisory board strategies
Domain
Biopharmaceuticals, Clinical Development, Regulatory Affairs
Required skills
Clinical scientist experience (Phases 1-3), Regulatory interaction expertise, Filing document preparation, KEE engagement, Advisory board management, Local regulation knowledge
Preferred skills
Global pharmaceutical company experience
Technologies
Clinical development tools, Regulatory submission systems
Responsibilities
Research medical environment and build relationships with KEEs, Prepare advisory board meetings, Review and provide expert input on clinical protocols and regulatory documents (CTD, J-PI, RMP), Prepare responses to PMDA inquiries, Contribute to publication strategy