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Максим

 Активно ищу работу

Head of DRA Ukraine / CIS; Medical Director

Киев 38 лет

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Вид занятости:

Полный день

Опыт работы:

Head of Regulatory department, Ukraine and CIS countries
с 12.2011 - по 04.2018 (6 лет 4 месяца)

MEDA Pharmaceuticals Switzerland GmbH A Mylan company (RO in Ukraine and CIS)  (Киев)
Фармацевтическая промышленость

Regulatory Affairs

-       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.

 Pharmacovigilance

-       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.

 Quality Assurance

-       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.

 Medical Affairs

-       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.

 Other

-       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.

Образование:

Bogomolets National Medical University  (Киев )

Год окончания  2003

Pharmaceutical faculty; Specialty: pharmacist; Specialization: Management and Marketing in Pharmacy

Medical school No 1  (Киев )

Год окончания  1998

Medical Laboratory Assistant

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