Manager II, CMC

Develop the CMC sections of the Briefing Book and Investigator's Brochure for PMDA consultation and execute IP management for clinical studies in Japan. Prepare registration documents, respond to PMDA inquiries, and review member submissions to provide technical advice. Directly exchange information with AST to advise on Japanese regulatory and scientific points, manage JAST-AST communications, and coordinate supply implementation plans. Propose CMC strategies to enhance productivity and support the Group Manager in functional activities. Create and execute a career development plan while attending external trainings and educating group members. Requires at least 10 years in drug development and 5 years in CMC labs or regulatory affairs, with knowledge of Japan's local regulations and IP-GMP activities.