Ruhsatlandırma Uzmanı / Kıdemli Uzman İş İlanı

İşveren Hakkında
  • İstanbul(Asya)(Kadıköy, Ataşehir)
  • İlaç Sanayi, Biyoteknoloji

GENEL NİTELİKLER

Responsibilities:

  • Preparation of submission documents for the registration of the Biotech products in local and international markets (including MENA, LATAM, North Africa, Asia)
  • Ensure timely registration of products in compliance with applicable regulation and guidelines.
  • Work collaboratively with countries Project Leaders to identify documents that require submission
  • Expedite and coordinate a multitude of interrelated activities for a submission team in the development of published submission within the required timelines.
  • Facilitate documents exchange for translation
  • Track metrics associated with submission planning and publishing reports & template for info
  • Plan and conduct cross-functional meeting


Requirements:

  • Min. Bachelor Degree in Pharmacy, Chemistry or Biology, master science in biotechnology is preferable.
  • Min. 3 years in the pharmaceutical or biopharmaceuticals regulatory affairs positions
  • Excellent command of Microsoft Office applications,
  • Ability to effectively communicate and influence others across functions
  • Ability to organize and lead project teams
  • Meticulous and detail-oriented
  • Able to start work immediately or within short notice
  • Fluency in written and verbal English,
  • No military obligation for male candidates,
  • Residing in the Asian Side of Istanbul.