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International Regulatory Affairs Executive

Sanovel İlaç

İstanbul(Avr.), İstanbul(Asya)

İş Yerinde

İş Yerinde

Job Type

Full-Time

Years of Experience

More than 7 years of experience

Department

Registration

Registration

Application Count

62 application

Job Type

Full-Time

Years of Experience

More than 7 years of experience

Application Count

62 application

Department

Registration

QUALIFICATIONS AND JOB DESCRIPTION

  • Bachelors degree in Chemistry, Chemical Engineering, Pharmacy, Molecular Biology and Genetics; master degree in relevant field will be preferred,
  • Minimum 7-8 years of International Regulatory Affairs experience in a pharmaceutical company,
  • Strong commitment to compatibility, scientific quality and integrity,
  • Knowledge and understanding of global regulatory procedures,
  • Leader in terms of performance, owning learning agility,
  • Having a high sense of empathy and being curious about everything new and unusual,
  • Managing relationships and responsibilities with collaboration,
  • Exellent command of English (both written and spoken),
  • Very good knowledge of MS Office applications.

JOB DESCRIPTION

  • Conducting and following up the correspondence for registered products, making variations required, preparing renewal dossiers for Non-Regular (CIS, MENA, Balkans, Africa, Asia-Pasific etc.) markets in English language,
  • Ensuring registration dossiers are prepared in CTD format for own developed products, variations required (Type I/II) in English languages, sending samples for analysis, getting licence and sales authorization,
  • Ensuring coordination and collaboration with concerned departments and Representatives Offices (Intellectual Property, Medical, Factory, Partners, Consulting Companies and Representative Offices) and taking a decision in common,
  • Managing of preparing, verifying and confirmation of all packaging materials from registration to exportation stages for all countries,
  • Ensuring registration dossiers are prepared in CTD format in English for products to be registered in new markets and sending the dossiers to consulting firm; providing/preparing required information and documents,
  • Controling all documents for GMP application to the Authorities in foreign countries, following up the GMP inspection process until receiving GMP certificate of conformity,
  • Following up international regulations and guidelines concerning registration and participating international seminars and exhibitions.

Preferred Candidate

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

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

Ruhsatlandırma Yöneticisi İş İlanları

Pharmaceuticals industry

Hakkımızda

Gücümüzü Değerlerimizden Alıyoruz… Her biri alanında yetkin ve işini tutkuyla yapan 1.500’ü aşkın çalışanımızla birlikte sağlıklı yarınlar, değerli

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KİŞİSEL VERİLERİN İŞLENMESİ HAKKINDA AYDINLATMA BİLDİRİMİ VE MUVAFAKATNAMESanovel İlaç Sanayi ve Tic

Detaylı Bilgi

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

Ruhsatlandırma Yöneticisi İş İlanları