Regional Submissions Planner
Core
Plan, coordinate, and review regional regulatory submissions for the EU + EEMEA region to ensure timely delivery to Health Authorities.
Role type
Regional Submissions Planner (Regulatory Operations)
Builds
Regulatory submission plans and documentation for pharmaceutical products
Domain
Pharmaceutical industry / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project management, Regulatory submission planning, Regulatory compliance, Process improvement, Cross-functional collaboration, Regulatory systems management
Preferred skills
eCTD familiarity, EU + EEMEA regulatory guidelines knowledge, Strategic initiative support
Technologies
Regulatory IT systems, Electronic Common Technical Document (eCTD)
Responsibilities
Develop and maintain regulatory submission plans aligned with milestones; Facilitate cross-functional meetings for submission execution; Manage regulatory systems and databases for tracking and reporting; Drive submission assembly and delivery with the Submission Publisher; Identify and implement process improvements; Support cross-regional activities and strategic initiatives.
Seniority
Mid-level, hands-on IC