The incumbent is responsible for Japan regulatory CMC strategies, submission dossiers and approvals, including direct contact/liaison with PMDA/MHLW, for development phase of projects and for Change Controls
Job Summary
The incumbent is responsible for Japan regulatory CMC strategies, submission dossiers and approvals, including direct contact/liaison with PMDA/MHLW, for development phase of projects and for Change Controls.
You would be able to gain extensive experience and knowledge across a variety of modalities including small molecules and biologics like antibodies, vaccines, and Cell & Gene Therapy Product.
We encourage a challenge and support each other under circumstance where psychological safety is ensured.
Matching Summary
The incumbent is responsible for Japan regulatory CMC strategies, submission dossiers and approvals, including direct contact/liaison with PMDA/MHLW, for development phase of projects and for Change Controls.
Skills & Requirements
Must-have
Japan regulatory CMC strategies
submission dossiers and approvals
liaison with PMDA/MHLW
Global Regulatory CMC&D Focal Points
post-marketed CMC change controls
develops innovative Japan regulatory CMC strategies
Nice-to-have
collaborative working relationships
internal and external Regulatory Policy Organizations
demonstrates behaviors that live and promote Sanofi Values
psychological safety is ensured
Key Requirements
Minimum of a Bachelor’s Degree
additional minimum 3 years of direct Regulatory CMC experience