Senior Associate or Manager, RA TA Group, Regulatory Affairs(Neurology)
Core
Execute regulatory affairs activities for assigned projects in the Neurology therapeutic area, ensuring timely submission of documents to PMDA/MHLW and supporting product life-cycle management.
Role type
Manager, Regulatory Affairs (Therapeutic Area Group)
Builds
Regulatory submissions (NDAs, PMDA consultations, Clinical Trial Notifications, package inserts) for neurology products
Domain
Pharmaceuticals / Regulatory Affairs / Neurology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Japan regulatory knowledge, regulatory submission preparation, cross-functional collaboration, regulatory strategy development, stakeholder communication, SOP development
Preferred skills
New drug development project experience, life-cycle management experience, experience managing communications with regulatory authorities
Technologies
PMDA systems, MHLW submission portals
Responsibilities
Prepare and submit regulatory documents to PMDA/MHLW; Collaborate with Clinical Development and Commercial teams; Lead regulatory strategies for global and local requirements; Monitor and interpret regulatory changes; Support development of regulatory SOPs
Seniority
Manager, hands-on IC