Job description
Lead regulatory strategy for new drug development and approval in Japan Manage PMDA consultations, submissions, and regulatory communications Prepare and review CTD dossiers and approval application documents Coordinate with global and cross-functional teams on regulatory activities Strong knowledge of Japanese pharmaceutical regulations and clinical trial requirements Requirements 4+ years of experience in regulatory affairs within the pharmaceutical industry Benefits Gain hands-on experience leading regulatory strategy and PMDA consultations for innovative new drug projects in Japan.
The role also offers strong exposure to cross-functional leadership and career growth into broader regulatory responsibilities.