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
Builds
Regulatory submission documents and approval pathways for new drugs in Japan
Domain
Biotechnology / Pharmaceuticals / Life Sciences
Required skills
Regulatory strategy, submission document preparation, stakeholder collaboration, risk assessment, meeting leadership, regulatory compliance, life cycle management, cross-functional execution
Preferred skills
Life/Health Sciences background, clinical research experience, drug development experience, innovative regulatory approaches
Technologies
Regulatory guidelines, submission platforms
Responsibilities
Lead development of Japan regulatory strategy 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
Seniority
Senior, Management