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Regulatory affairs manager

Киев от 20000 грн

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Вид занятости:

Не имеет значения

Навыки и достижения:

• 2006 — internship at the Military Medical Academy, specialization — general pharmacist.
• 2005 — graduated from the National Medical University OO Bogomoletz, Faculty of Pharmacy, specialization — general pharmacia.
• 1997-1999 – Business school at Kyiv economical institute of management, specialization – marketing and PR-technologies.

• 12.2013 – until now. «…», Germany. Regulatory Affairs Manager.
• My responsibilities included regulatory functions to accelerate registration, renewal and support procedures of variations of medical products and medical devices. • Monitoring and setting timelines for licence variations and renewal approvals.
• Negotiating with regulatory authorities for marketing authorisation.
• GMP certification.
• Pharmacovigilance.

• 07.2013 – 12.2013 «…», Germany. Regulatory Affairs Manager. Duties: In general my activities are solving all issues related to the registration process, variations, including regulatory processes in line with corporate strategy and Ukrainian laws.
• Receiving registration certificates in time, providing necessary regulatory and documentary support during the validity of the registration certificates.
• Ordering registration dossiers on the production facilities in time and in compliance with requirements from the Ministry Of Health of Ukraine, preparing them for submission to the registration authorities. • Translating the necessary parts of the dossier and guarantee the accuracy of the translation.
• Controlling, observing and providing informational support for submitted registration dossiers at different stages of the registration/re-registration/amending processes.
• Holding negotiations, collecting questions and submitting the responses to the Regulatory Authorities in timely manner to accelerate obtaining of the positive decisions concerning the Company’s products.
• Checking the text on the package materials and ensuring their compliance with approved.
• Collecting changes in the field of health care that can affect the Company’s activities and informs the Company’s management and the relevant departments thereof in time.
• GMP certification.
• Registration medical devices.

• 01.2012 – 06.2013 «…», Austria. Regulatory Manager. Duties: document preparation for registration, re-registration and introduction of changes of medicines; pharmacovigilance; GMP certification; quality control certificate medicines which are imported; declaration prices, registration medical devices.

• 05.2011 – until now. «…», Ukraine). Regulatory Affairs Manager. Legal support agreements and search of clients in CIS countries.

• 10.2006 – 12.2011 – LLC «…», Ukraine.
01.2009 – 12.2011
Head of the department of registration and re-registration medicines in CIS countries.
— document preparation for registration, re-registration and introduction of changes of medicines;
— monitoring, data collection and analysis of information from government services related to the company;
— registration of trademarks and obtain patents for invention.
01.2008 — 12.2008
— promotion of products to pharmacies and pharmacy chains, pharmaceutical distributors;
— support of contract relationships with existing clients;
— new customers acquisition;
— performing sales and distribution development plans;
— analysis of current situation at the entrusted territory;
— reporting preparation according to the corporate requirements;
— communication with employees of external service, logistics and marketing department.
10.2006 — 12.2007
— procurement of reagents and materials for laboratory research and experiments with registered and new medicines;
— searching, analyzing and purchasing equipment for the manufacturing and laboratory, which is needed for new medicine development;
— correspondence on the international level;
— administrator of the company internet site.

• 09.2005-09.2006 – Pharmacist-intern, MC «Pharmacy», Kyiv.
• 09.2004-09.2005 – Pharmacist, MC «Pharmacy», Kyiv.

General information:
• High level computer skills.
• Languages: Ukrainian and Russian – native, English – Upper-intermediate, Deutsch – novice.
• Driver’s license «B», since 2003.
• Family: Married, have a son and daughter.
• Personal qualities: responsible, communicable, punctual and purposeful.
• Set up productive relationship with UA government regulatory agencies.
• Location – Kyiv, Ukraine.