Regulatory Affairs Specialist

Roche A.Ş.

Qualifications

• A university degree in Pharmacy, Chemistry or Chemical Engineering
• At least 5 years of Regulatory Affairs experience in a pharmaceutical company
• Excellent command of English (both written and spoken)
• Multitasking and ability to work cross-functionally
• Analytical thinking
• Good teamwork collaboration 

Job Description

• Ensure that the dossiers to be submitted to the Ministry (GMP audit, new product or new indication application) are obtained from the global headquarters, translated, and controlled
• Compile all additional documents requested by the Ministry for the application dossier after obtaining them from the global headquarters or preparing them locally and submit the application to the Ministry within the earliest time possible
• Foresee the necessary processes and act proactively in order to accelerate registration approval process
• Ensure the coordination and information exchange with medical departments and business units during the new product / new indication approval process and align with the common strategy,
• Conduct the necessary correspondences for all registered/non-registered products
• Demand and procure the necessary sample and materials and submit them to the Ministry with necessary documents when they needed to be analysed by the Ministry
• Make registration renewal applications
• Inform the Ministry beforehand when licence withdrawal is necessary and conduct the necessary correspondences