Regulatory Affairs Specialist

Manpower Suadiye

• 1-2 years experience in regulatory/quality departments of pharmaceutical industry,
• Medical device regulatory knowledge is preferable,
• Graduate from: pharmacy, chemistry or life-science field,
• Takes initiative and is committed to excellence, is able to work under pressure, flexible, and willing to learn,
• Approaches tasks and projects systematically and with analytical thinking,
• Fluent in Microsoft Office (Word, Excel, Power Point),
• Fluent in English, both spoken and written (required),
• Team player, customer focused, communicates and solves problems effectively,
• Works precisely, is detail oriented,
• Autonomous, has mental grasp / is quick minded,

İŞ TANIMI

• Handling requests and submissions of regulatory files,
• Responsible for processing changes related to change of name of legal manufacturer, manufacturing sites, authorized representative Turkey,
• Coordinate artwork activities in the context of changes of Marketing Authorization Holders and other changes related to the spin-off,
• Supporting and managing submission of variations for drugs and notifications for medical devices
• Helping with registration activities in non-EU countries,
• Active participation in day-to-day Regulatory Affairs activities and projects,
• Track submissions and archiving documentation,