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Male, 52 years, born on 11 June 1973

Moscow, metro station Seligerskaya, not willing to relocate, prepared for occasional business trips

Regulatory Affairs Officer/Specialist/Manager

95 000  in hand

Specializations:
  • Sales manager, account manager

Employment type: part time, project work/one-time assignment

Work experience 18 years 7 months

March 2004December 2018
14 years 10 months
•CJSC «ALSI Pharma» (Russia, production of finished medicinal forms)

Moscow, www.alsi.ru

Medicine, Pharmaceuticals, Pharmacies... Show more

Leading Manager in Medical and Pharmaceutical Information
 Preparation and formation of documents together with quality control department and other departments of the enterprise, compilation and submission of regulatory dossier into Ministry of Healthcare (MoH) of Russian Federation;  Introduction of amendments into officially approved normative documentation;  Writing a draft version of Patient Information Leaflets (a kind of SPC);  Translation of Certificates of Analysis, Monographs from foreign Pharmacopeias and other specialized documents from/into English;  Administration and control over registration stages like Pharmaceutical Expertise of Quality and/or Bioequivalence Trials and Risk/Benefit rate investigation;  Collaboration with regulatory bodies (MoH, Roszdravnadzor), including such subjects like level of prices, selective control, pharmacovigilance (PSURs), correspondence with Federal Stately Budget Institution “Scientific Center of Medical Remedies’ Expertise” which applies to registration/regulatory issues (answers for their requests);  Development and approval (within our enterprise) of draft packaging materials for mass-producing and new preparations;  Work with “Uniscan (EAN)/GS1 Russia” Association of automatic identification (numbering of bar-codes);  Archiving of documents according to System of Management Control (ISO 9001), development of SOPs within the scope of Regulatory Department;  Taking part in problem resolution/settlement which concerns reclamations or quarreling, but only within the competence of Leading Manager of Regulatory Department, and also during all the stages of product life cycle;  Providing of medical information about products into reference sources for specialists like doctors and pharmacists (publications: publicity and advertising).
April 2003September 2003
6 months
•OJSC "Pharmaceutical Import, Export" ("Pharmimex")

Moscow, www.pharmimex.com

Medicine, Pharmaceuticals, Pharmacies... Show more

Main specialist of import sector of the procurement department
 Carried out deliveries of imported commodities (15 firms) of the pharmacy assortment: medicines and some other goods;  Controlled placement of orders, their preparing and execution; worked with contracts on delivery and with tenders on delivery; controlled payments over the contracts;  Entered the delivery data into SAP/R3 system.
February 2002February 2003
1 year 1 month
•“Biotec” Ltd. (Russia, distribution)

Moscow, www.biotecmos.ru

Medicine, Pharmaceuticals, Pharmacies... Show more

Manager of procurement department (import)
 Carried out deliveries of imported medicines according contracts with foreign supplies or producers (15 firms);  Booking-on and placement of orders on the basis of sales department’s demands, analyzed the price competition, controlled placement of orders, their preparing and execution; worked with contracts on delivery and with tenders on delivery; controlled payments over the contracts and indebtedness;  Negotiated with suppliers.
December 1999February 2002
2 years 3 months
•“Longvi-Pharm” Ltd. (Russia, sales of umbrella brands “cytamines” and “cytamedines”)

www.citamin.ru

Medicine, Pharmaceuticals, Pharmacies... Show more

Deputy head of the warehouse
 Promotion of new products (so called “Cytamins” and “Cytomedines” (Cortexin, Rethinalamin)) and interaction with pharmaceutical organizations such as wholesalers, pharmacies, taking part in “pharma-circles” and numerous exhibitions;  Found a room for opening a new pharmaceutical warehouse, took part in obtaining of an operational license (wholesale trade);  Completed orders, primary accounting.

Skills

Skill proficiency levels
• Knowledge of registration process and procedures in Russian Federation (expertise and authorizatio
• Elaboration and teamwork coordination of specific information before submitting it to regulatory a

About me

Single. My strong features are: responsibility, orientation to result and quality of work being done.

Portfolio

Higher education

1996
Higher education
Moscow Medical Academy named after I.M.Setchenov
Pharmaceutical, Pharmacy

Languages

Russian — Native

English — B2 — Upper Intermediate

German — A2 — Elementary

Professional development, courses

2018
Short-term seminars (“International User Forum of the United States Pharmacopeia (USP)”),
in October 2013 and October 2015-2017-2018, Russia
2013
Postgraduate refresher courses for specialists, who are in charge of quality, packaging and labeling of medicines, including Authorized persons.
First Moscow State Medical University named after I.M.Setchenov, department of industrial pharmacy within pharmaceutical faculty, Russia, Pharmacy
2004
Seminars in May 2012 (“Modern requirements for packaging, labeling and storage of medicines”), in December 2009 (“Expertise of medicines’ effectiveness and safety”); in February 2008 (“Problems of intellectual property issues in medicines’ circulation sphere”), in February 2005 (“The basics of Good Registration (Regulatory) Practice. Enhancement of approaches in Regulatory Affairs. Reference standards”).
Russia, Pharmacy

Tests, examinations

2014
English language courses
Denis' School (2014); Speak Up (2010); State courses №12 in Moscow (1991), Colloquial and written English; business and medical-pharmaceutical vocabulary specialization

Citizenship, travel time to work

Citizenship: Russia

Permission to work: Russia

Desired travel time to work: Up to one hour