Regulatory Affairs and Compliance Manager at Amgen
United Arab Emirates
- Current
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- Regulatory Affairs and Compliance Manager at Amgen
- Past
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- Regulatory Affairs Manager at GlaxoSmithKline
- Regulatory Affairs Assistant Manager at GlaxoSmithKline
- Regulatory Affairs Specialist at GlaxoSmithKline
- Regulatory Affairs Associate at Eczacibasi
- Education
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- Bogaziçi Üniversitesi
- Bogaziçi Üniversitesi
- Marmara Üniversitesi
- Notre Dame de Sion
- Sisli 19 Mayis Ilkokulu
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ASLI YUKSEL’s Summary
ASLI YUKSEL’s Specialties:
- Government Liaison
- Regulatory Affairs (new products submission and approval, relationships with MoH, merger activities, maintenance of the existing products)
- Pricing of pharmaceutical products (pricing of the new and existing products)
- Reimbursement of pharmaceutical products
ASLI YUKSEL’s Experience
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Regulatory Affairs Manager
GlaxoSmithKline
(Public Company; 10,001 or more employees; Pharmaceuticals industry)
October 1999 — February 2008 (8 years 5 months)
Job context:
• 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.
• Lobbying 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 scale for approval of new product indications and packaging component texts.
• Maintain concordant relationships with her counterparts in other pharmaceutical companies, which are strategic allies or co-marketing partners and assist them in regulatory matters.
• Keep abreast of changes/developments in local and international regulatory guidelines, pricing decrees and notifications and make the necessary arrangements to implement them within the company. -
Regulatory Affairs Assistant Manager
GlaxoSmithKline
(Public Company; 10,001 or more employees; Pharmaceuticals industry)
January 1999 — October 1999 (10 months)
She was responsible for regulatory submission, registration, pricing and reimbursement of all new GW products. She co-ordinated 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.
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Regulatory Affairs Specialist
GlaxoSmithKline
(Public Company; 10,001 or more employees; Pharmaceuticals industry)
March 1997 — December 1998 (1 year 10 months)
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Regulatory Affairs Associate
Eczacibasi
(Privately Held; 5001-10,000 employees; Pharmaceuticals industry)
January 1996 — March 1997 (1 year 3 months)
ASLI YUKSEL’s Education
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Bogaziçi Üniversitesi
Executive MBA , Master of Business Administration , 2002 — 2003
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Bogaziçi Üniversitesi
BSc , Chemical Engineering , 1990 — 1995
- Activities and Societies:
- Environmental Society
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Marmara Üniversitesi
Chemistry Education 1988 — 1990
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Notre Dame de Sion
Highschool , 1980 — 1988
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Sisli 19 Mayis Ilkokulu
primary School , 1975 — 1980
Additional Information
ASLI YUKSEL’s Websites:
ASLI YUKSEL’s Interests:
Scuba diving Bridge
ASLI YUKSEL’s Contact Settings
Interested In:
- career opportunities
- consulting offers
- new ventures
- job inquiries
- expertise requests
- business deals
- reference requests
- getting back in touch
