Summary
Overview
Work History
Education
Skills
Languages
Youth Exchanges
Timeline
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Iveta Darguze

Iveta Darguze

Vilnius

Summary

Results-driven RA Specialist at Thermo Fisher Scientific with extensive experience in regulatory affairs, specializing in eCTD document preparation and submission while ensuring compliance with global regulatory standards. Holds a Master's in Physical Sciences (Medical Chemistry) and a Bachelor's in Technological Sciences (Industrial Biotechnology). Skilled in authoring and reviewing regulatory documents, proficient in managing project timelines, and collaborating with regulatory bodies. Proven track record of leading successful team initiatives, demonstrating exceptional communication skills, and innovative problem-solving abilities. Committed to achieving excellence in regulatory affairs through continuous learning and dedication to delivering positive outcomes.

Overview

9
9
years of professional experience

Work History

Regulatory Affairs Specialist

Thermo Fisher Scientific Baltics
01.2022 - Current

Ensured compliance with U.S. FDA and Health Canada regulatory requirements on ancillary materials.

Preparation of DMFs in eCTD format, and other CMC regulatory packages.

Processed requests from competent authority efficiently. ISO9001, ISO13485

Sr. Quality Assurance Specialist

Thermo Fisher Scientific Baltics
06.2024 - 02.2025

Regulatory Affairs Specialist

Interchemie werken “De Adelaar” B.V.
09.2020 - 01.2022

Coordinated EMEA veterinary medicine registration efforts. eCTD, DMFs, etc.

Sales Manager

UAB FUDO, Kaunas
02.2020 - 07.2020

Administrator

Green Acres Motel, Lake George, NY
06.2019 - 09.2019

Medical Administrator

Affidea Lithuania, Kaunas
09.2018 - 10.2018

Jack&Jones Store Manager

UAB URGE, Kaunas
10.2016 - 09.2018

Education

Master of Physical Sciences - Medical Chemistry

Lithuanian University of Health Sciences & Kaunas University of Technology
Kaunas, Lithuania
06.2020

Bachelor of Technological Sciences - Industrial Biotechnology

Kaunas University of Technology
Kaunas, Lithuania
06.2018

Skills

  • Communication
  • Highly Organized
  • Attention to details
  • Creative Problem Solving
  • Executive team leadership
  • Staff training
  • Business Process Improvement, PPI
  • eCTD ISO standards

Languages

Lithuanian
Bilingual or Proficient (C2)
English
Advanced (C1)
Spanish
Elementary (A2)

Youth Exchanges

  • Work&Travel US 2019
  • Youth Exchanges “Inspiration”, Istanbul, Turkey FEBRUARY 2020 — FEBRUARY 2020
  • Youth Exchanges “Keep it Interactive ! Foster the Engagement !”, Bova Marina, Italy OCTOBER 2023

Timeline

Sr. Quality Assurance Specialist

Thermo Fisher Scientific Baltics
06.2024 - 02.2025

Regulatory Affairs Specialist

Thermo Fisher Scientific Baltics
01.2022 - Current

Regulatory Affairs Specialist

Interchemie werken “De Adelaar” B.V.
09.2020 - 01.2022

Sales Manager

UAB FUDO, Kaunas
02.2020 - 07.2020

Administrator

Green Acres Motel, Lake George, NY
06.2019 - 09.2019

Medical Administrator

Affidea Lithuania, Kaunas
09.2018 - 10.2018

Jack&Jones Store Manager

UAB URGE, Kaunas
10.2016 - 09.2018

Master of Physical Sciences - Medical Chemistry

Lithuanian University of Health Sciences & Kaunas University of Technology

Bachelor of Technological Sciences - Industrial Biotechnology

Kaunas University of Technology
Iveta Darguze