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Experiences

Past Experience

  • Regulatory Affairs Product Liaison
    September 2013 --- September 2017

    Complete life-cycle overview for the assigned product portfolio, including planning, dossier
    assembly, preparation of local documentation, writing dossier summaries, submission
    tracking, etc. regarding various submissions (Original, Renewals, variations) to healthcare
    authorities in Slovenia (EU), Albania, and Kosovo.

  • Student in Regulatory Affairs
    September 2008 --- September 2013

    Preparation and submission of applications to regulatory authorities.

  • Pharmacy Intern in Community Pharmacy
    February 2012 --- June 2012

  • Undergraduate Research Fellow at Inorganic Chemistry Department
    July 2010 --- July 2010

Personality

Self Assessment :
Analytical thinkingCollaborationEfficiencyProblem solvingSelf-discipline

Knowledge

LinkedIn Assessment :
Regulatory affairsCMC Regulatory AffairsRegulatory submissionsFood & Drug LawRegulatory FilingsQuality AssuranceRegulatory ComplianceRegulatory DocumentationRegulatory RequirementsGMPRegulatory guidelinesCMCPharmaceutical IndustryElectronic Common Technical Document (eCTD)Common Technical Document (CTD)NeeSStandard Operating Procedure (SOP)Microsoft ExcelMicrosoft OfficeHealthcareEnglishResearchMedical DevicesProject+

Education

  • Master of Pharmacy in Pharmaceutical Sciences from University of Ljubljana in 0

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
SLOVENIAN
Native
Spanish
Elementary Proficiency

Work Preferences

  • Notice Period:
    3 weeks
  • Positions I am interested in:
    Regulatory Project Manager Regulatory Affairs Manager Regulatory Affairs Consultant Director Regulatory Affairs Regulatory Affairs Associate Quality Assurance (QA) Manager Associate Scientist CMC Manager CMC Project Manager Compliance Manager QA Officer QA Lead Qualified Person Scientific Writer
  • Locations I am interested in:
    Belgium Canada Ireland Switzerland
  • Work From Home:
    No
  • International:
    Yes

Area / Region

Slovenia

Others

Driving License
  • Yes