Regulatory Affairs Specialist / Executive (Temp.)


  • Company:
    ASTRAZENECA PHARMA INDIA LTD
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    4 days ago
  • Category:
    Biotechnology/Pharmaceutical/Medicine | Manufacturing/Industrial

Location , Istanbul, Turkey QUALIFICATIONS University degree from reputable universities (Preferably from Pharmacy, Chemistry, Chemical Engineering, Biology departments) Advanced command of written and spoken English, Preferably regulatory work experience in a pharmaceutical company Min 1 year of Regulatory Affairs experience for Specialist position Min 4 years of Regulatory Affairs experience for Executive position Advanced knowledge in MS Office applications, High interpersonal, communication and presentation skills, Good at teamwork, Good at follow-up and strong planning skills, No restriction for travel, No military obligation for male candidates. JOB DESCRIPTION The incumbent of the position will be responsible for the following duties, on a 1-year-contract basis; Preparation of registration and variation files according to current Ministry of Health requirements, Approval of registrations and sales Permissions, Preparation of SmPC/PIL submissions, Manage the written correspondence with Ministry of Health before and after registration approval, Follow up global and local regulatory requirements, Maintain and update global and local regulatory systems. Regulatory Affairs Specialist / Executive (Temp.) Regulatory