The incumbent regulatory professional is accountable for Japan strategic management of a portfolio of development projects and post-marketed products within Global regulatory CMC & Devices Japan
Job Summary
The incumbent regulatory professional is accountable for Japan strategic management of a portfolio of development projects and post-marketed products within Global regulatory CMC & Devices Japan.
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 regulatory professional is accountable for Japan strategic management of a portfolio of development projects and post-marketed products within Global regulatory CMC & Devices Japan.
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
CMC dossier preparation
Nice-to-have
innovative strategies and risk assessments
collaborative working relationships
internal and external Regulatory Policy
develops CMC technical skills
psychological safety is ensured
Key Requirements
Minimum of a Bachelor’s Degree
Business level of English fluency
Minimum 3 years direct Regulatory CMC experience
Knowledge of Japan & global regulations/guidelines