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Summary

I recieved almost 2 years experience in dealing with registration process on an international level in the leading pharmaceutical company RUE ”Belmedpreparaty” in the Republic of Belarus. I have extensive skills in new drug products registration and maintenance of registration of approved drug products in CIS countries(Azerbaijan, Uzbekistan, Armenia) as well as in all registration related activities. To ensure successful registration I had to collaborate with external partners and with authorities directly, that strongly influenced on my communication skills development. Work with a huge amount of medical drugs simultaneously contributed to my rapid growth in the profession,taught me the exact planning and to work within strict deadlines.

Experiences

Past Experience

  • Regulatory Affairs Associate
    July 2011 --- December 2012
    • gathering and preparing of technical documentation, its editing and proofreading • compiling of the full dossiers for submissions internationally in three regions (Azebaidjan, Armenia, Uzbekistan) • writing of periodic safety update reports (PSUR) • re-writing of the instructions for medical use for patients according with newly received information about drug adverse effects as well as editing of these instructions according with regulatory organs requirements • response preparations to the questions of experts • intensive collaboration with regulatory departments as well as external partners to ensure successful registration/re-registration • contracts/agreements drafting and signing • maintain accuracy of budget and budget expenses for registration process • samples packing and shipping in the quality control laboratories • normative documents adjustment according to the expert comments • timely manner actualization of normative documentation • work coordination of all departments in the pharmaceutical company in accordance with newly approved standard documentation

  • Customer Service Advisor (part time student job)
    May 2011 --- June 2011
    • Handling and tracking incoming customer calls • Clients advising about the production • Solving customer’s questions, problems, requests • Entering data in system

  • Pharmaceutical Sales Representative (part time student job)
    January 2011 --- May 2011
    • active cooperation with provisors and pharmacists • conducting of marketing campaigns and seminars to provide an opportunity to get more information about products • merchandising

Knowledge

LinkedIn Assessment :
administration skillsdrug registrationgathering, preparing, editing and proofreading of technical documentationintensive collaboration with regulatory departments as well as external partnetimely manner actualization of normative documentation• maintain accuracy of budget and budget expenses for registration processwriting of periodic safety update reports (PSUR)Regulatory affairsPharmaceutical IndustryDocumentationLife SciencesPharmaceuticsRegulatory submissionsExperience in chromatographic techniquesExperience in spectroscopic techniqueswork experience with human and animals hemoglobin

Education

  • Bachelor's degree in Biology in Biochemistry from International Sakharov Environmental University (ISEU) in 2011

Training and Certification

  • Certificate of Attendance at Spanish normative grammar and language specialty Certification
  • Certificate of Attendance English language courses at the normative grammar and language specialty Certification
  • Certificate of participation in the conference of young scientists, graduate students, undergraduates, students in 2010 Certification
  • Diploma 2nd degree for The best research project in the speciality "medical and biological business'' Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
Russian
Native
Spanish
Professional Proficiency
Dutch
Elementary Proficiency

Area / Region

Maastricht, Netherlands

Others

Driving License
  • No