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КиевКиев 39 лет
MEDA Pharmaceuticals Switzerland GmbH A Mylan company (RO in Ukraine and CIS)
- Organization of regulatory department for activities in Ukraine and CIS countries (12 countries); controlling and coordination of regulatory activities in countries.
- Cooperation with HAs and partners in Ukraine and CIS countries.
- Monitoring of pharmaceutical market development and changes in regulatory legislation for timely trends identification that may affect the process of products registration.
- Conduction of registration process in Ukraine and CIS countries (ordering and preparation of necessary documents and materials (dossier, normative documentation, SPC/PIL) for registrations, renewals and variations, negotiating with HA for MA; preparation and approval of packaging materials).
- Ensure appropriate archiving of regulatory relevant documentation belonging to registration dossiers and correspondence with HAs in line with the corresponding procedures.
- Cooperation with local and corporative Supply Chain, Marketing, Legal and Finance departments.
- Budget activity.
- Organization and coordination of PV system according to corporate and local requirements (carrying out of trainings for staff, preparing SOPs, CIOMS reporting, etc.).
- Preparation and closing of CAP after internal PV audits.
- Conduction of GMP confirmation process for PIC/S and non-PIC/S facilities in Ukraine.
- Organization and preparation of necessary documents for re-packaging process in Ukraine (Quality Agreement, SOPs).
- Cooperation with State Inspection and laboratories.
- Organization and participation in off-sites GMP Inspections with Belarus HA.
- Creation and approval of SOP for marketing (promotional) materials.
- Checking and approval of marketing (promotional) materials as well as materials for medical representatives’ trainings.
- Integration of ethical promotional in Marketing department.
- Conduction of price registration process in Azerbaijan, Kazakhstan, Moldova, Ukraine.
- MA transfer projects.
- Integration of RA, QA and PV systems of Rottapharm-Madaus into MEDA system.
- Integration of RA, QA and PV systems of MEDA into Mylan system.
Год окончания 2003
Pharmaceutical faculty; Specialty: pharmacist; Specialization: Management and Marketing in Pharmacy
Год окончания 1998
Medical Laboratory Assistant
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