Ozlem Kosar Email & Phone Number

İstanbul, Türkiye

• Control marketing authorisation applications and follow-up the progress
• Control variation applications and follow-up the progress
• Control license renewal applications and follow-up the progress
• Control deficiency letters and follow-up the progress
• Follow-up all processes for all registered and non-registered products
• Follow-up regulations and developments and changes in the regulatory systems

Turkey

• Preparation and submission of Marketing Authorisation applications to Turkish MoH in CTD format.
• Preparation, submission and follow up of variation, renewal and marketing authorization transfer applications.
• Regulatory activities of medicinal products, medical devices, food suplements and cosmetics.
• Responding deficiency letters or questions of Turkish MoH during registration process.
• Submission of SmpC and PIL.
• Providing requiered documents to Pharmacovigilance Department for preparation of PGGR.

Turkey

• Preparation of CTDs, e-CTDs for new submissions of MoH and other regulatory authorities
• Preparation of variation documents
• Coordination of documentation with regulatory authorities, MoH and related departments
• Evaluation, preparation, submission and follow-up of registration files for all new products and also maintenance of all existing portfolio
• Submission and follow-up of variation, renewal and marketing authorization transfer applications
• Preparation & renewals of SmPCs, PILs and inner-outer package designs for new submissions and current product range

Istanbul, Turkey

• Preparation of CTDs for new submissions of MoH and other regulatory authorities
• Preparation of variation documents
• Coordination of documentation with regulatory authorities, MoH and related departments
• Evaluation, preparation, submission and follow-up of registration files for all new products and also maintenance of all existing portfolio
• Submission and follow-up of variation, renewal and marketing authorization transfer applications
• Preparation & renewals of SmPCs, PILs and inner-outer package designs for new submissions and current product range

Istanbul, Turkey

• Process incoming customer requests and orders.
• Determine export controls applicable to the order and coordinate efforts with the regulatory compliance team as needed.
• Completing foreign trade data requirements, generating export documents in SAP.
• Assure on-going regulatory compliance for the order and ensure accuracy of export documents and charges.
• Check the orders against the customer and purchase order agreements.
• Respond to customer product inquiries and satisfaction issues.

Istanbul, Turkey

• Analytic method development and validation of new products
• Stability studies
• Preparation of relevant parts of regulatory affairs
• Purchasing studies

Istanbul, Turkey

Ms, Organic Chemistry

Bs, Chemistry