Regulatory Manager
On-site · Tokyo, Tokyo, Japan
Job Summary
Regulatory Manager responsible for Japan regulatory CMC strategies and liaison with PMDA/MHLW, managing development and post-marketed CMC activities, drafting and submitting regulatory dossiers, coordinating with Global CMC&D FP and R&D/M&S teams, and contributing to policy and strategy discussions to ensure compliant regulatory support for development projects and products. Requires knowledge of Japan regulatory requirements and global guidelines, experience preparing regulatory dossiers, ability to lead technical/regulatory discussions, and business English proficiency; position involves collaboration with internal and external stakeholders and potential mentoring of staff.
Required Qualifications
- Bachelor's Degree in science/health field or equivalent
- Advanced degree desirable (Masters/PhD)
- Technical pharmaceutical CMC experience (QC laboratory, manufacturing)
- Minimum 3 years direct Regulatory CMC experience (5+ may apply)
- Business level English fluency
- Knowledge of Japan regulatory dossier requirements and global regulations/guidelines
- Ability to communicate effectively with internal and external audiences
- Experience with interactions with Health Authorities (PMDA/MHLW) is helpful but not essential
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