Senior Manager, Regulatory Affairs
Core
Lead the development and implementation of regulatory strategy for new drug projects in Japan, serving as the regulatory representative and contact with Japanese Health Authorities.
Role type
Senior Manager, Regulatory Affairs (Japan)
Builds
Regulatory submission packages and approval pathways for new drugs in Japan
Domain
Biotechnology / Pharmaceuticals / Life Sciences
Deliverable
client delivery
Required skills
Regulatory strategy development, submission document preparation, stakeholder collaboration, risk assessment, cross-functional leadership, regulatory compliance, life cycle management
Preferred skills
Life/Health Sciences background, clinical research experience, drug development experience, innovative approach to regulatory solutions
Technologies
None stated
Responsibilities
Lead Japan regulatory strategy alignment across all development stages; Provide end-to-end leadership for regulatory submissions; Lead interactions with Japanese Health Authorities; Identify and mitigate regulatory risks; Propose innovative regulatory solutions beyond conventional precedents
Seniority
Senior, Management level
