Regulatory Manager
Core
Strategic management of development projects and post-marketed products for Japan regulatory CMC & Devices, including submission dossiers, approvals, and liaison with PMDA/MHLW.
Role type
Senior regulatory manager (CMC & Devices)
Builds
Regulatory submission dossiers and change control packages for pharmaceutical development and post-marketing
Domain
Pharmaceuticals, Regulatory Affairs, CMC (Chemistry, Manufacturing, and Controls)
Required skills
Japan regulatory strategy, PMDA/MHLW liaison, CMC dossier preparation, change control management, risk assessment, global regulatory alignment, technical CMC knowledge
Preferred skills
Advanced degree in science/health, technical pharmaceutical CMC experience, Health Authority experience, mentorship capability
Technologies
Regulatory submission systems, CMC writing tools
Responsibilities
Develop Japan regulatory CMC strategies and risk assessments; Liaise directly with PMDA/MHLW for CMC topics and quality consultations; Manage post-marketed CMC change controls and regulatory impact assessments; Prepare and review regulatory CMC dossiers for submission; Contribute to global regulatory strategy documents; Monitor and interpret local/international Health Authority regulations and guidelines
Seniority
Senior, strategic management with hands-on execution