Manager, Regulatory Affairs
Tokyoonsitemanager
Posted today · via Workday
About this role
Job title: Manager, Regulatory Affairs Location: Tokyo About the job Role & Responsibilities The R&D Regulatory Affairs has responsibility for managing products under development and/or marketed products with new indications. Develop regulatory strategy for new drug developments, Health Authority meetings and Japan New Drug Submission (J-NDA) and provide regulatory expertise within project/product teams for products under development and/or marketed products. Prepare Japanese Common Technical Documents (J-CTD) for the regulatory submission and arrange the internal review of J-CTD. Lead the preparation of Clinical Trial Notification (CTN), Health Authority meetings (e.g. PMDA Consultation Meetings) and major regulatory submission (e.g.…
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.
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