Regulatory Affairs Professional

• Nov 2021 - Present

Regulatory Affairs Manager

• Sep 2020 - Nov 2021

Regulatory Affairs Manager

• Mar 2019 - Jul 2020

• Manager of global regulatory affairs of medicinal products (e.g. vaccines, parenteral solutions and tablets). • Writing CTD dossiers (Module 1, 2, 3) by working closely with departments such as production, quality control, quality assurance departments. • Providing answers to any kind of questions coming from Agencies. • Updating MA dossiers after ensuring that the data supplied by other departments are in compliance with regulations/guidelines. • Preparation and submission of variation dossiers, following up the submissions. • Preparation of inner/outer box labels in compliance with the relevant regulations/guidelines issued by Turkish Ministry of Health. • Editing SmPC and PIL prepared by relevant department to ensure that they are in compliance with relevant regulations/guidelines issued by Turkish Ministry of Health. • Acting as the regulatory advisor to departments such as quality control, quality assurance and sales & marketing. • Overseeing colleagues’ work on submissions. • Preparation of registration dossiers of registered products in European Union in compliance with the relevant regulations/guidelines issued by Turkish Ministry of Health by communicating with international licensers and following up the submissions. • Preparation of GMP submission dossiers for local and global sites, following up the submissions. • Preparing the necessary dossiers for products to export in compliance with the relevant export country’s regulations. • Preparation of Sample Analysis Dossiers in compliance with the relevant regulations/guidelines issued by Turkish Ministry of Health • Following current European and Turkish regulations. • Managing communications with international licensers. • Creating and maintaining SOPs. • Managing pricing and reimbursement applications. Show less

Regulatory Affairs Manager and Corporate Affairs Officer

• Jan 2016 - Feb 2019

• Responsible person for global regulatory affairs of radiopharmaceuticals. • Preparation of MA dossiers of registered products in European Union in compliance with relevant regulations/guidelines issued by Turkish Ministry of Health and following up the submissions. • Preparation and submission of variation dossiers, following up the submissions. • Preparation of inner/outer box labels, SmPC, PIL in compliance with relevant regulations/guidelines issued by Turkish Ministry of Health. • Preparation of Sample Analysis Dossiers in compliance with the relevant regulations/guidelines issued by Turkish Ministry of Health. • Following current European and Turkish regulations. • Preparation of GMP submission dossiers and management of GMP audit process. • Managing communications with international licensers. • Medical device product & document registration and managing all the processes on ÜTS system (national medical device database) to ensure their continuity. • Creating and maintaining SOPs. Show less

Project Assistant

• Aug 2013 - Jul 2015

• Performing research under master’s degree programme. • Method development, validation and implementation. • Performing analyses and compiling results. • Laboratory maintenance. • Preparation of MA dossier under the relevant project. • Performing research under master’s degree programme. • Method development, validation and implementation. • Performing analyses and compiling results. • Laboratory maintenance. • Preparation of MA dossier under the relevant project.