Experience

Maxicells İlaç Sanayi A.Ş.

• Türkiye
• Biotechnology Research
• 1 - 100 Employee

• Regulatory Affairs Director

  • Jan 2019 - Present

  • Coordinate Regulatory Affairs, Govermental Affairs, Market Access (Pricing/Reimbursement/Product Positioning), Pharmacovigilance & Medical Regulatory Affairs, Artwork Processes, Quality, Import Permissions • Managing Know – How transfer from Global Biological Product Manufacturing Company from Germany. • Leading Toll Fractionation Project and Localisation of Plasma Derivative Products as first localisation project in Turkey. • Coordination relations with SSI, Turkish Red Crescent (Türk Kızılayı), Licence and Know-How Holder Company • Coordination for establishment of Plasmapheresis centers in Turkey. • Managing QA System based on Finished Product and Plasma Raw Materials in line with local and EU GMP regulations. • Managing preparations of Local and EMEA (EU) inspections for Regional Blood Centers of Turkish Red Crescent and Maxicells Plasma Frozen Warehouse Show less



DEVA Holding A.Ş.

• Türkiye
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Group Manager

  • Feb 2009 - Jan 2018

  • Managing 5 departments : Regulatory Affairs, Pricing – Reimbursement & Market Access, Goverment Relations, Medical Regulatory Affairs, Artwork [Printed Materials] • Managing submission process of registration dossiers (annually about 100 dossiers) • Managing variation submissions with cross functional units • Managing all correspondences with Ministry of Health and other authorities before and after registration • Managing reimbursement and pricing processes and preparation of product positioning evaluations • Coordinate all units (25 team members) workflow and cross functional communications and direct report to Chairman. • Coordinate and communicate with the companies for imported products • Managing Pharmacovigilance System, SPC/PIL publications, MA renewals, PSURs, medical RA support for e-CTD and reimbursement dossiers. • Managing all printed materials and their specifications of portfolio (for about 700 registered products and 100 under registration products) • Member of Product Steering Committee (PSC). Reporting to committee for new pipeline products and establishing product strategy regarding registration type/process, pricing, reimbursement and regulatory wise product positioning. • Support Business Development, R&D and Export departments regarding documentation. • Support preparation of Capital Markets Board reports, Financial Audit Company Reports, Credit Lender Reports regarding registered products, under registration products • Support top management presentations for Shareholders, Global Events and Annual Activity Reports • Coordinate and manage official representation on behalf of Group Company and lobby activities at Ministry of Health (MoH), Social Security Institution (SSI). Show less



Recordati

• Italy
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Manager

  • May 2006 - Feb 2009

  • Managing submission of registration dossiers for local and international market • Managing variation submissions with cross functional units • Managing all correspondences with Ministry of Health and other authorities before and after registration • Managing reimbursement and pricing processes • Coordinate regulatory affairs team (10 team members) workflow and cross functional communications • Support to Business Development • Managing MA renewals, PSURs • Coordinate Bioequivalency studies • Coordinate and manage official representation on behalf of company and lobby activities at Ministry of Health (MoH), Social Security Institution (SSI) Show less



Exeltis

• Spain
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Assistant Technical Manager

  • Jun 2005 - May 2006

  • Coordinate and manage pharmaceutical drug analyzes (for reports, preparation of master plans about formulation, analytical method devolopments and validations • Project planning with Gantt Schemes for pipeline products • Production Process Design for lane production study • Coordinate and manage SOP writing and documentation • ISO 9001:2000 Practices and Audits • Contact with contract manufacturer and supplier abroad. • Technical support to Regulatory Affairs according to CTD format documentation. • Experiences in GMP audits of ISO, Schering - Bulgaria, Bulgarian Health Authority, Ranbaxy-India, Turkish Health Authority Show less



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• R&D Specialist

  • Jun 2004 - May 2005

  • Perform validation of analytical methods (assay, dissolution, impurity) with TSP and HP Agilent Liquid Chromatography, Sotax Dissolution, Shimadzu Photometric analysis • FDA granted laboratory experience • Calibrating laboratory devices • Reporting all analytical method validations and calibrations. • Perform validation of analytical methods (assay, dissolution, impurity) with TSP and HP Agilent Liquid Chromatography, Sotax Dissolution, Shimadzu Photometric analysis • FDA granted laboratory experience • Calibrating laboratory devices • Reporting all analytical method validations and calibrations.