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Regulatory and Quality Manager / Qualified Person (FvP) (80% to 100% position)

Position

1) Regulatory Affairs

  • Supervision of regulatory activities for the Belgian affiliate, including new applications and life-cycle management (variations, renewals...)
  • Maintenance of product registrations and communication with competent authorities (i.e. for drug products, medical devices and food supplements)
  • Applications for product's reimbursement
  • Creation and approbation of product information and packaging (legal/regulatory aspects)

    2) Quality

  • Maintenance of distribution licence , responsibility for GDP and GMP compliance
  • Responsibility of Qualified Person (FvP)
  • Batch review and release for Belgium market
  • Handling of quality-related issues on Belgium market (i.e. complaints, deviations...)
  • Supervision of Quality System and related documentation (SOPs, work instructions)
  • Training of the staff on quality, pharmacovigilance and GDP topics

    3) Pharmacovigilance

  • Local responsible person for Pharmacovigilance
  • Reporting of PV cases to competent authorities

    4) Scientific support

  • Handling of technical requests (from customers and HCP)
  • Scientific and regulatory support to internal staff (e.g. medical reps, marketing)
  • Control and approval of advertising and promotional material
  • Profile

  • Scientific educational background (preferably Pharm)
  • Previous experience in Regulatory / Quality Assurance, within the pharmaceutical industry
  • Good knowledge of Belgium pharmaceutical market and legislation
  • Team player, reliable, precise, motivated
  • Fluency in French and Flemish, good level of English
  • Contact

    Claudine Lachman