Specialist, Regional Submission Planner
Core
Plan and manage regulatory operation projects and submission plans for the AP region, ensuring timely delivery to country regulatory affairs teams and Health Authorities.
Role type
Specialist, Regional Submission Planner
Builds
Regulatory submissions and documentation for pharmaceutical products
Domain
Pharmaceutical industry, Regulatory Affairs
Required skills
Project management, Regulatory submission planning, Cross-functional collaboration, Process improvement, Regulatory systems management, Multicultural environment navigation
Preferred skills
eCTD knowledge, Enterprise Project Management (EPM), Project Cycle Management (PCM), Time pressure management, Complex IT systems affinity
Technologies
Enterprise Project Management (EPM), Project Cycle Management (PCM), Regulatory systems and databases
Responsibilities
Plan and manage regulatory operation projects from authorization through delivery; Develop and maintain regulatory submission plans and milestones; Facilitate cross-functional forums for submission activities; Drive submission assembly and delivery with publishing teams; Maintain knowledge of regional regulatory procedures and guidelines.
Seniority
Specialist, operational level