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İlan Detay

Firma Adı Gizli

Licensing Specialist

İstanbul Anadolu, İstanbul Avrupa

Firma Adı Gizli - Licensing Specialist

Job Definition

  • Having a quality focused mind-set
  • Handling preparation of the registration files in high quality to submit to the Ministry of Health within the refined KPIs.
  • Ensuring that the Company’s products comply with the regulations of the local Health Authority
  • Speeding up the initiation of the registration procedures.
  • Shortening the registration period for quick access to the market with the favourable labelling information.

Qualifications

Preparing the registration file according to the regulation.

(New Drug Application, New Indication, Line Extension, variations, renewals, etc)

  • Reporting of adverse events that are proclaimed by physicians, pharmacists, patients and all other parties to Patient Safety Department in time and in compliance to relevant company SOP
  • Follow- up the registration steps on the process.
  • Monitoring reporting and setting timelines for the variations, renewals, pharma vigilance related activities, databases.
  • Ensuring the consistency of Health Authority approved Regulatory Affairs information throughout other units.
  • Initiating the process for Health Authority approved packaging materials.
  • For defined therapeutic areas of responsibility, providing full regulatory support across the related Business units.
  • Being an interface between several line units.
  • Keep up- to-date with government legislation as it relies to regulatory affairs.
  • Effective planning and management of prioritization process for GMP and MA submission.
  • Monitoring reporting and setting timelines for the variations, renewals, pharmacovigilance related activities, databases