Ozlem Kosar Email & Phone Number

Turkey

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.•Ensuring that packaging texts for components are drafted and revised as necessary in line with the labeling regulations, review and approve packaging artwork.•Submission of price applications. Preparation, submission and follow up of reimbursement applications. •Follow-up of developments and changes in the regulatory, reimbursement and pricing systems.

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• Preparation of SOP for regulatory affairs• Applying for submissions to MoH via WEB interface

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• Preparation of SOP for regulatory affairs• Translating Drug Master Files to Turkish• Applying for submissions to MoH via WEB interface

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.•Instruct and liaise with warehouses, plants and forwarders to prepare and arrange the execution of the shipment of goods.•Create and monitor outbound activities in order to complete the order.•Invoice timely and accurately.•Handle complaints and return shipments.•Interface with and support the sales representatives.•Maintain, update and file customer files, records and internal documents

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