Bu ilan yayından kaldırılmıştır.

Licensing Specialist

İstanbul Avrupa Yakası, İstanbul Anadolu Yakası
  • 16.07.2021
  • 0 - 50
  • 1945 Görüntüleme

Job Description

  • 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.

Required Skills

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

Summary Info

Benzer İlanlar

MOBILCODE YAZILIM OTOMASYON
İstanbul Avrupa Yakası, İstanbul Avrupa Yakası - Sarıyer
Bugün
ÇAMLICA BARKOD BİLG. SİST.SAN.TİC.LTD.ŞTİ.
İstanbul Anadolu Yakası
Bugün
Empatik İnsan Kaynakları
İstanbul Avrupa Yakası
Bugün
Konya, Türkiye
Bugün
TACİRLER YATIRIM MENKUL DEĞERLER A.Ş.
İstanbul Avrupa Yakası - Beşiktaş
Bugün
Konya, Türkiye
Bugün
HERA İNSAN KAYNAKLARI EĞİTİM VE DANIŞMANLIK LİMİTED ŞİRKETİ
İstanbul Anadolu Yakası
Bugün
YENİKAN YAZILIM DANIŞMANLIK VE EĞİTİM HİZMETLERİ LTD.ŞTİ.
İstanbul Avrupa Yakası
Dün
İstanbul Avrupa Yakası
Dün
GURU SİSTEM YÖNETİM VE YAZILIM SAN.TİC. LTD.
İstanbul Avrupa Yakası - Bahçelievler
Son 1 Hafta
BENZER TÜM İLANLAR