ASLI YUKSEL
Bis 2010, Regulatory Affairs and Market Access Professional
Luleburgaz, Türkei
Werdegang
Berufserfahrung von ASLI YUKSEL
Bis heute 13 Jahre und 5 Monate, seit Jan. 2011
Regulatory Affairs Manager
Zentiva Health Products
3 Monate, Okt. 2010 - Dez. 2010
Regulatory Affairs and Market Access Professional
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2 Jahre und 4 Monate, Juni 2008 - Sep. 2010
Regulatory Affairs and Compliance Manager
Amgen
• Ensure that the local affiliate management is kept up to date on the implementation of key legislation, regulatory policy and regulatory guidance. • Ensure that local processes, strategies and initiatives are aligned with regulatory requirements and pricing guidelines defined by Amgen International and Global Groups.
• Supervise acquisition of all technical, medical, legal, regulatory documentation and information from GSK R&D, co-marketing partners and contract manufacturers for compilation of registration dossiers. • Monitor collation and preparation of supporting documentation to obtain Group acceptable prices for new products. • Lobby with the reimbursement committee members to include GSK products into the reimbursement lists. • Liaise with MOH officials in Ankara on a weekly basis in order to minimize the time
2 Jahre und 7 Monate, März 1997 - Sep. 1999
Regulatory Affairs Asst. Manager
Glaxo Wellcome
Responsible for regulatory submission, registration, pricing and reimbursement of all new GW products. Coordinated the flow of regulatory information between the Regulatory Affairs Department in Turkey and the International Registration Department in the UK to meet launch date objectives. Submitted 12 new product dossiers and obtained registration certificates of 5 new products during this period.
Ausbildung von ASLI YUKSEL
2002 - 2003
Bogazici University
1990 - 1995
Chemical Engineering
Bogazici University
Sprachen
Englisch
Fließend
Französisch
Fließend
Türkisch
Muttersprache