Mag. karolina dobrychlop

Reportable and standard complaints handling Conducting investigations for medical devices, acting as a safety officer Reportable field actions coordination Control and approve on regular basis cross organizational complaint audits in order to ensure correct classification and handling Communication with the Authorities

Preparing and filling the necessary forms for registration of the products with the relevant Regulatory Authorities Maintain communication with the Regulatory Authorities of the RMS for the initiation of the procedure Module 1, 2 and 3 preparation Submission of the dossier to the competent Regulatory Authorities Preparation and submission of the response documents Preparation and submission of response documents Regulatory strategy recommendations

Coordination of registration processes for products transfered to Poznan GMS (factory/site) Comply with GMP, QMS and pharmacutical law standards Identification of potential EHS risks, EHS risks’ managment and escalation QMS and quality standards training performance Preparation, opinion giving and approval of quality documentation Attendence in quality incidents, deviations, CAPA process, postaudit recommendations and complaints Participation in internal and external audits

Registration and renewals process coordination for products transferred Regulatory support for new products introduction projects Regulatory documentation assessment within transfer process Implementation managing in aspect of: regulatory strategy, milestones in project schedule, team management Cooperation with Main Pharmaceutical Inspector Cooperation with Embassies in aspect of documents legalization process Medical samples dispatch

Variations, renewals, first registrations and administrative documents Regulatory documentation assessment within transfer process Cooperation with LE (clients) on markets EMEA and FDA requirements familiarity Regulatory procedures knowledge: MRP, CE, CD Regulatory requirements for API’s (Active Substance) knowledge (EDMF/CEP; USDMF) Word-wide GMP and regulatory requirements knowledge

stem cells and genetics