External Regulatory Affairs Senior Specialist

Onko İlaç Tic. A.Ş.

We are looking for an "External Regulatory Senior Specialist" to be employed in our factory equipped with advanced technology in Gebze Organized Industrial Zone.

• Graduated from the Pharmacy, Chemistry, Chemical Engineering, Molecular Biology and Genetics departments of universities
• Excellent command of English both in writing and speaking is must, additional languages is an asset,
• Minimum of 5 years of experience in the External Regulatory process
• Proficiency in MS Office Set  (Word, Excel, Powerpoint, Access),
• Ability to time management and problem solving skills,
• Willingness and potential for learning and development,
• Strong planning and coordination skills, good communication skills,
• Analytical thinking, result and detail oriented,
• Military Service must be completed for male candidates.

JOB DESCRIPTION

• Preparing the license files by making the necessary translations in accordance with the legislation of the countries operating in the International Markets, completing the missing information and documents by contacting the relevant departments and submitting the application to the Ministry of Health,
• By contacting the distributor company in International Markets, responding to all relevant requests before the license application, during the licensing and after the receive license, and maintaining relations with the authority of the relevant country,
• Have full knowledge of with EU and FDA legislation and regulatory processes regarding licensing, preparation of the license application file in line with international, EU and FDA directives, monitoring and execution of all activities,
• Following the processes of licensed products, making variation applications for licensed and licensing products,
• Ensuring the continuity of the license by making license renewal applications for licensed products,
• Making updates to the license file upon the request of the countries operating in International Markets,
• Having knowledge about EU and FDA registration submissions and carrying out tasks within the organization during the audit process