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Pharma Regulatory Publisher

Mandatory:
DESCRIPTION

Job details

  • Job locationBudapest, 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"
REQUIREMENTS
  • 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

ARE YOU THE PERFECT CANDIDATE?
Pharma Regulatory Publisher