Ruhsatlandırma Uzmanı / Kıdemli Uzman

CinnaGen İlaç San. Ve Tic. Aş.

Responsibilities: 

• Preparation of documents for the registration of the Biotech products.
• Ensure timely submission of registration submission deficiency letter responses, variations in compliance with applicable regulation and guidelines.
• Work collaboratively with Project Leaders to complication of required documents
• 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.