Summary
Overview
Work History
Education
Skills
Websites
Certification
Additional Information
Languages
GDPR consent statement
Timeline
Generic
Anna  Duda

Anna Duda

Gdansk,22

Summary

Regulatory Affairs specialist with 3 years of experience seeking a job in Regulatory Affairs field. Looking for a new job opportunity where my experience and education can be use for well-being of the company.

Overview

4
4
years of professional experience
1
1
Certification

Work History

Senior Regulatory Affairs Specialist

Cognizant
02.2022 - Current
  • Provides senior review, advice and staff training in the customer process.
  • Daily cooperation with local representatives of the company (Europe, Africa, GCC, EAEU).
  • Automating and streamlining processes to improve project delivery efficiency.
  • Compilation, publishing and quality control of regulatory submissions.
    (eCTD, NeeS, paper submission, folders with local structure).
  • Compilation of documentation for CTA process.

Junior Regulatory Affairs Specialist

Cognizant
09.2020 - 01.2022
  • Ensuring high-quality formatting of files by creating hyperlinks, bookmarks and optimization.
  • Compilation and publishing of regulatory submissions
    (eCTD, paper submission, folders with local structure).
  • Preparation of electronic dossier for IMPD, Pediatric Investigation Plans, CMC Reports, Scientific advices,
    nonclinical reports.
  • Daily cooperation with local representatives of the company (Europe, GCC, Africa).
  • Quality checking of documents (CMC, non-clinical, clinical) with internal requirements of the company.

Junior Quality Analyst

Grupa Żywiec S.A.
04.2020 - 09.2020
  • Collection of laboratory samples in accordance with the control plan.
  • Operation and maintenance of technical efficiency of machines and devices through control, cleaning and calibration.
  • Control of physicochemical and microbiological parameters of the wort and beer during the production.
  • Quality control of finished product.

Education

Postgraduate Degree - Conducting And Monitoring Clinical Trials

Kozminski University
Warszawa
03.2022

Master's Degree - Entrepreneurship And Quality Science

Gdynia Maritime University
Gdynia
09.2019

Master's Degree - Biotechnology

Gdańsk University of Technology
Gdańsk
07.2017

Bachelor's Degree - Chemistry

University of Gdańsk
Gdańsk
12.2015

Skills

  • Clinical Trials
  • Teamwork
  • Regulatory Affairs
  • ICH GCP
  • Regulatory Requirements
  • Microsoft Office
  • Microsoft Excel
  • Adobe Acrobat
  • LORENZ DocuBridge
  • Quality control
  • ISO
  • Document Control
  • Insight Publisher

Certification

  • Regulatory Affairs Specialist, Kariera w Farmacji - October 2022
  • Spanish course B.1.1 (CFER) , Language Center of the University of A Coruña - October 2018
  • Environmental management system assistant (PN-EN ISO 14001) , Polskie Centrum Badań i Certyfikacji S.A. - June 2018
  • Internal auditor of quality management system according to ISO9001:2015, PCC-CERT Polskie Centrum Certyfikacji - November 2017
  • Application of GC-MS in chemistry and environmental protection , pro-science.eu - June 2015
  • Good Manufacturing Practice Specialist in the Cosmetic Industry - GMP (ISO 22716:2007) , isoQRS - May 2015

Additional Information

Universidade da Coruña- 2018 - Participation in the International Student Exchange program - Erasmus +

Mentor - Erasmus Student Network - 2019-2020:

Languages

English
Advanced (C1)
Spanish
Upper intermediate (B2)
Polish
Bilingual or Proficient (C2)

GDPR consent statement

I agree to the processing of personal data provided in this document for realising the recruitment process pursuant to the Personal Data Protection Act of 10 May 2018 (Journal of Laws 2018, item 1000) and in agreement with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).

Timeline

Senior Regulatory Affairs Specialist

Cognizant
02.2022 - Current

Junior Regulatory Affairs Specialist

Cognizant
09.2020 - 01.2022

Junior Quality Analyst

Grupa Żywiec S.A.
04.2020 - 09.2020

Postgraduate Degree - Conducting And Monitoring Clinical Trials

Kozminski University

Master's Degree - Entrepreneurship And Quality Science

Gdynia Maritime University

Master's Degree - Biotechnology

Gdańsk University of Technology

Bachelor's Degree - Chemistry

University of Gdańsk
Anna Duda