Experience

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  BIOFARMA Pharmaceutical

  • Türkiye
  • Pharmaceutical Manufacturing
  • 700 & Above Employee

  • Domestic Regulatory Affairs Administrator

    • Apr 2013 - Sep 2015

    • Develop and coordinate implementation of regulatory strategies• Coordinate domestic regulatory team work flow weekly and monthly• Responsible for coordination & preparation of regulatory submissions for new developed products in compliance with the local legislation and guidelines (CTD submissions), maintenance of these documents, • Manage the final product submissions, negotiate and communicate effectively with regulatory authorities to obtain timely product approvals,• Implementing of variation applications for both registered & on-registration products, preparation and renewal of SmPc and PILs.• Coordinate, follow-up and check all correspondence with Ministry of Health before and after registration• Ensure coordination between domestic regulatory affairs team and related departments• Follow-up trademark registration process for both registered & on-registration products• Follow-up change management system and coordinate related variation submission• Follow-up alternative source project for registered products• Take an active role in due diligence process

  • Domestic Regulatory Affairs Assistant Administrator

    • Apr 2012 - Mar 2013

  • Regulatory Affairs Senior Specialist

    • Jan 2009 - Mar 2012

  • Regulatory Affairs Specialist

    • Jan 2008 - Dec 2008

  • Regulatory Affairs Assistant Specialist

    • Mar 2006 - Dec 2007

• 

  Deva Holding A.Ş.

  • R&D Analyst

    • Aug 2003 - Jul 2005