Regulatory Affairs Specialist

CinnaGen İlaç San. Ve Tic. Aş.

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:

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