Sr. Manager, Regulatory Affairs
Core
Senior Manager leading regulatory strategy, submissions, and lifecycle management for development and commercial programs in Japan.
Role type
Senior Manager, Regulatory Affairs
Builds
Regulatory submissions and approvals for pharmaceutical/biotech products in Japan
Domain
Pharmaceutical/Biotechnology, Japan Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy development, Health Authority interaction, submission preparation, project management, cross-functional collaboration, compliance management
Preferred skills
Advanced degree, experience with orphan designation/expedited pathways, CRO/vendor management
Technologies
PMDA/MHLW systems, clinical trial notification platforms
Responsibilities
Develop and execute Japan regulatory strategies aligned with global objectives; Lead preparation and submission of documents to PMDA/MHLW (CTNs, Marketing Authorization Applications, Orphan designation); Coordinate responses to Health Authority inquiries; Manage regulatory plans and timelines for assigned programs; Partner with Clinical, Medical, Quality, CMC, and Commercial teams; Provide guidance to team members for capability development.
