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İlan yayından kaldırılmıştır
İstanbul(Avr.), İstanbul(Asya)

İş Yerinde

İş Yerinde

Job Type

Full-Time

Years of Experience

1 - 5 years of experience

Department

Administrative / Clerical

Administrative / Clerica...

Application Count

540 application

Job Type

Full-Time

Years of Experience

1 - 5 years of experience

Application Count

540 application

Department

Administrative / Clerical

QUALIFICATIONS AND JOB DESCRIPTION

Job Description

 

-        Having a quality focused mindset

-        Handling Preparation of the registration files in high quality to submit to the MOH 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.

 

Major Accountabilities

-        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 Drug Safety & Epidemiology Department in time and in compliance to relevant Novartis 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 HA approved RA information throughout other units.

-        Initiating the process for HA approved packaging materials.

-        For defined therapeutic areas of responsibility, providing full regulatory support across the related Bus.

-        Being an interface between several line units.

-        Being a SPOC for the coordination of site GMP inspection submission.

-        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


Key Performance Indicators

 

-        To realize the yearly product plan.

 

 

 

 

 

Preferred Candidate

Bachelor’s(Graduate)
English(Reading : Advanced, Writing : Advanced, Speaking : Advanced)

Yasal İşler Uzmanı pozisyonu ile ilgili daha detaylı bilgi almak ya da diğer iş fırsatlarını incelemek için aşağıdaki sayfaları inceleyebilirsiniz.

Yasal İşler Uzmanı Yasal İşler Uzmanı Maaşları Yasal İşler Uzmanı Nasıl Olunur? Yasal İşler Uzmanı Nedir? Yasal İşler Uzmanı İş İlanları
Hakkımızda

Novartis Sağlık, Gıda ve Tarım Ürünleri San.

Şirket Sayfasına Git

Yasal İşler Uzmanı pozisyonu ile ilgili daha detaylı bilgi almak ya da diğer iş fırsatlarını incelemek için aşağıdaki sayfaları inceleyebilirsiniz.

Yasal İşler Uzmanı Yasal İşler Uzmanı Maaşları Yasal İşler Uzmanı Nasıl Olunur? Yasal İşler Uzmanı Nedir? Yasal İşler Uzmanı İş İlanları