|職名||CMC RA Associate/Manager|
|勤務地||Japan - Tokyo|
Global Pharmaceutical Company
・Creation of CMC-related materials for development and post-marketing maintenance and regulatory response
Target items: Chemical synthetic products, antibody drugs and regenerative medicine products, Medical Devise (combination products)
・RA CMC to cover all modalities such as small molecule, antibody , cell & gene therapeutic products, radiopharmaceutical and medical devices at both development and post market phases.
・Provide high quality and robust CMC regulatory strategies and documents to support business needs in development and post market maintenance.a.CTD module 3 in collaboration with global RegCMC
B. QOS (Module 2)
C. Application Form
・ University Degree Or Equivalent (Preferred Education: Biochemistry, Genetic Engineering, Cell And Molecular Biology, Immunology, Chemical Synthesis, Analytical Chemistry)
・Fluent English As Business Language
・ Over 3 -years experience in CMC related business area
・Experience of development, manufacturing, analytical testing and / or CMC regulatory for biologics products such as antibody drugs Experience of research, development and / or manufacturing for regenerative medicine especially for cell and gene therapies.