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İlan yayından kaldırılmıştır
İstanbul(Avr.)(Beşiktaş)

İş Yerinde

İş Yerinde

Job Type

Full-Time

Years of Experience

No experience preference

Department

Registration

Registration

Application Count

246 application

Job Type

Full-Time

Years of Experience

No experience preference

Application Count

246 application

Department

Registration

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QUALIFICATIONS AND JOB DESCRIPTION

Regulatory Affairs Specialist

Turkey – İstanbul

One of the most admired pharmaceutical companies, Novo Nordisk, is looking for a new teammate for its Regulatory Affairs Unit!

About the Department

Regulatory Affairs Unit is responsible for local strategies to obtain and maintain marketing authorisations for Novo Nordisk’s new products; and life cycle management activities such as new indications, CMC activities and GMP processes.

We aim to be the best Regulatory Affairs unit in the global pharma industry, being true business partners and continuously improving our performance while offering our people a great place to work. 

The Job

  • Prepare the registration files sent by Head Quarter (HQ) in the specific format required by the local regulatory authority
  • Prepare GMP files, accompany GMP inspections with inspectors, follow-up of CAPAs; and manage communication with all stakeholders throughout the process
  • Conduct CMC, labelling and safety updates of product registration files in a timely manner and respond effectively to all product registration modifications requested by the HQ/local authorities
  • Conduct effective negotiation with health authority when needed
  • Create and manage strong relationships with internal and external stakeholders
  • Be an effective business partner for the commercial units; initiate effective cross-functional collaborations for fast regulatory approvals, create and keep competitive labels
  • Represent Regulatory Affairs in internal brand teams by providing relevant input on strategy and actions
  • Monitor competitive intelligence on relevant therapeutic areas
  • Monitor local environment for developments in regulations and provide relevant information to key internal and external stakeholders and advise on necessary actions about changing regulations
  • Be the owner of the quality documents related to regulatory issues and ensure compliance

Qualifications

You are expected to hold a university degree in Pharmacy, Chemical Engineering or Chemistry, have 3-years experience in related area in the pharma industry, have advanced level of written and spoken English. The male candidates are expected to have no military obligation. 

Working at Novo Nordisk

At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes, haemophilia and growth hormone disorders. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development. 

Deadline:30.09.2019

Preferred Candidate

Bachelor’s(Graduate), Master’s(Student), Master’s(Graduate), Doctorate(Student), Bachelor’s(Student), Doctorate(Graduate)
Completed, Exempt

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Hakkımızda

Novo Nordisk Sağlık Ürünleri Tic. Ltd. Şti.

Şirket Sayfasına Git

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

Ruhsatlandırma Uzmanı Ruhsatlandırma Uzmanı Maaşları Ruhsatlandırma Uzmanı Nasıl Olunur? Ruhsatlandırma Uzmanı Nedir? Ruhsatlandırma Uzmanı İş İlanları