Pharma Regulatory Publisher

Job details

• Job location: Budapest, Hungary, 9th District, Mill Park office building
• Role type: permanent
• Full time employment, 40 hours/week in general working order
• Hybrid work option available

Job responsibilities

• Tracking different regulatory submissions (CRC/MAA/PSUR/PSUSA/RMP/Renewal) in the corporate regulatory database: update database with specific documents and/or information
• Peer-QC data entry – handling internal tracking
• Running daily queries, providing reports to client stakeholders
• Applying technical knowledge to perform quality check on the entries
• Communicating issues/concerns to Team Lead
• Ensuring compliance with KPIs
• Coordinating with other teams and client LRAs if necessary 
• Associates to ensure Training & compliance to applicable CTS and BI "Quality
• Management System"

• Bachelor degree in life sciences/pharmacy or comparable
• 0-2 years of experience in Regulatory Affair or Pharmacovigilance
• English (full working proficiency)
• Good verbal and written communication skills
• Experience with regulatory databases is an advantage