Senior Manager, CMC Regulatory (CMC Senior Expert, CMC Regulatory)
Core
Senior Manager leading CMC regulatory strategy, risk assessment, and submission execution (CTN, JNDA/sJNDA, CTD) for pharmaceutical development in Japan, bridging global teams and local authorities.
Role type
Senior Manager, CMC Regulatory (Japan)
Builds
Regulatory submissions (CTN, JNDA, sJNDA, CTD), risk management plans, and lifecycle change management for pharmaceutical products.
Domain
Pharmaceutical / Biotechnology / Regulatory Affairs
Required skills
CMC regulatory strategy, risk assessment, CTD/JNDA/sJNDA preparation, GMP/GCTP inspection support, lifecycle management, cross-functional leadership, negotiation, coaching
Preferred skills
Biotherapeutics/regenerative medicine submission experience
Technologies
CTD, JNDA, sJNDA, CTN, GMP, GCTP, Japanese Pharmacopoeia
Responsibilities
Conduct risk assessments and develop risk management plans; Lead regulatory discussions with global teams and authorities (PMDA); Prepare and review CTN, JNDA, sJNDA, and CTD documents; Support GMP/GCTP inspections; Manage lifecycle changes and variation applications; Provide technical advice on manufacturing processes and excipients.
Seniority
Senior Manager, hands-on IC with team leadership