Regional Submission Planner Senior Specialist
Core
Plan, coordinate, and execute regulatory submissions for pharmaceutical products across the EU and EEMEA regions to ensure timely approval by Health Authorities.
Role type
Senior Regulatory Submission Planner
Builds
Regulatory submission packages and documentation for Health Authorities
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 operations, Process improvement, Regulatory compliance, Cross-functional collaboration, Strategic planning
Preferred skills
Drug regulatory affairs, Pharmacovigivance, Regulatory strategy development, IT systems proficiency
Technologies
Complex regulatory IT systems, tools, and platforms
Responsibilities
Lead planning and coordination of complex regional regulatory submissions; Develop and maintain regulatory submission plans; Drive submission assembly and delivery; Manage regulatory systems and databases; Identify and implement process improvements; Collaborate with internal and external stakeholders; Maintain knowledge of evolving regulatory requirements.
Seniority
Senior, hands-on IC
