CMC Regulatory Manager
Tokyoonsitemanager
Posted today · via Workday
About this role
Job title: CMC Regulatory Manager Location: Hatsudai, Tokyo About the job Role & Responsibilities 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. 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. The incumbent creates collaborative working relationships with Global Regulatory CMC&D Focal Points (FP), Japan Regulatory Group, Technical and Quality Groups within R&D and Manufacturing and Supply (M&S), Regulatory Health Authorities, Others.…
What we'd score you on
reqspace match rubricFive dimensions, recruiter-grade. Upload your resume and we'll generate a written explanation of where you fit and where the gaps are.
1
Skills match
For this role: r, teams
2
Level fit
This role is manager-level. We check your trajectory against it.
3
Domain experience
Your work in the role's domain matters more than your years total. We weight recent and direct experience.
4
Recency
A skill you used last quarter weighs more than one from five years ago. We grade on recency, not lifetime.
5
Location fit
This role is based in Tokyo. We weight your proximity and willingness to relocate.
Score yourself on this role.
Free · no card · written explanation included
Skills in this role
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