RA Manager/Senior Manager (Hybrid/Remote)
Posted Updated
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.