Manager, Regulatory Submission Project Management
Core
Drive planning, execution, and review of regulatory operations activities for Japan business area, ensuring consistency and standardization across submissions.
Role type
Manager, Regulatory Submission Project Management
Builds
Regulatory submissions (PMDA, FDA, EMA) for life-changing medicines
Domain
Pharmaceuticals / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission process management, PMDA/FDA/EMA/ICH guidelines knowledge, eCTD format expertise, cross-functional team coordination, submission timeline management, EDMS management (Veeva Vault RIM, docuBridge), document review and validation
Preferred skills
None stated
Technologies
Veeva Vault RIM, docuBridge, MS Office, Adobe Acrobat
Responsibilities
Ensure consistency and standardization across regulatory submissions; Provide operational support for PMDA consultations, Clinical Trial Notifications, PCAs, MCNs, and NDAs; Coordinate planning and execution of submission timelines and responsibility matrices; Guide cross-functional groups to resolve regulatory issues; Partner with Regulatory Affairs to meet key milestones; Manage submission deliverables in regulatory EDMS; Review and validate submission documents for compliance
Seniority
Manager, hands-on IC
