Experience

PAION AG

• Germany
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director of Regulatory Affairs

  • Aug 2022 - Present



Medpace

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Manager

  • Apr 2022 - Jul 2022



AbbVie

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Manager

  • Apr 2021 - Mar 2022

• Regulatory Affairs Specialist

  • Jun 2019 - Apr 2021



Bayer

• Chemical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Specialist

  • May 2016 - May 2019

  - Responsible for defined regulatory projects - Plan the registration application times under the leadership of Regulatory Affairs Manager and share the anticipated approval times with related parties (i.e. Business Units, Supply Chain, Global Regulatory Affairs, etc.) and inform all who are concerned in the company about any changes on committed time - Under the leadership of Regulatory Affairs Manager, provide the application files from related areas, prepare the registration application files in accordance with the local regulations and present it to Ministry of Health (MoH)/ Ministry of Agriculture (MoA) in order to register new products (refers to Rx, non-Rx, medical devices, cosmetics, food supplements, etc.) - In order to continue the authorization validity of the registered products, follow up the application deadline and gather the required documentation from GRA - In order to complete the approval of registration applications of the products, follow up the evaluation processes at the MoH and ensure to fulfill their demand - Follow-up of developments and changes in the local & global regulatory policy rules - Ensure the CMC/labeling compliance - Artwork coordination and approvals - Actively participate to the meetings and represent the company at Association of Research Based Pharmaceutical Companies (AIFD) and/or other relevant associations related with regulatory - Develop proactive and reactive strategies to ensure improvement of registration approval process - Build and develop a network with regulatory related stakeholders Show less



Rada Ruhsat Destek Hizmetleri

• Türkiye
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Specialist

  • Jul 2014 - Apr 2016

  - Preparation of Marketing Authorization Application Dossier in CTD format as per the regulatory guidelines and Quality systems - Preparation of variation files in line with the current regulations - Preparation of Patient Information Leaflets (PIL) and Summary of Product Characteristics (SPC) as per the current regulations - Preparation of Marketing Authorization Application Dossier in CTD format as per the regulatory guidelines and Quality systems - Preparation of variation files in line with the current regulations - Preparation of Patient Information Leaflets (PIL) and Summary of Product Characteristics (SPC) as per the current regulations



Zentiva

• Czechia
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manufacturing Intern

  • Aug 2013 - Sep 2013



UNIDO-ICHET

• İstanbul, Türkiye

• Laboratory Intern

  • Aug 2011 - Sep 2011