REGULATORY AFFAIRS AND LOCAL QPPV(Embedded Solution)

Tasks

• Adapt to QRD requirements
• Advise clients and manufacturers
• Collect and evaluate scientific data
• Compile eCTD
• Coordinate local product quality release
• Coordinate pharmacovigilance activities
• Coordinate product dossier execution
• Ensure regulatory compliance
• Manage dossier development teams
• Manage dossier maintenance
• Monitor international legislation and guidelines
• Negotiate with regulatory authorities
• Prepare SmPC
• Prepare labeling and PIL
• Provide regulatory strategy advice
• Serve as local QPPV point of contact
• Submit pricing and reimbursement procedures
• Support product registration
• Use eCTD management software
• Validate eCTD submissions

Perks/Benefits

• Partial remote work options
• Professional development opportunities

Skills/Tech-stack

Data evaluation | Dossier preparation | ECTD | ECTDmanager | Lorenz Validator | Medical Labeling | Pharmacovigilance | QRD Templates | RAEFAR | Regulatory Compliance | Regulatory strategy | SMPC | Scientific Data | Scientific Data Evaluation