Regulatory Affairs Change Management

CURRICULUM VITAE

Name Teglas, Petra Phone work

Address Seattle, WA 98125 Phone private +1-347-***-**** Email *****.******@*****.*** LinkedIn Petra.Teglas SHORT PROFILE

Regulatory Affairs Specialist with 1.5 years’ experience supporting global submissions and lifecycle management for diagnostics and medical devices, plus 5+ years in biomedical research; MSc in Biomedical Science; Skilled in change management, regulatory documentation, GAP analyses, and cross-functional collaboration; Proficient with Veeva Vault

(RIM MedTech), agile practices, and ensuring GMP and international regulatory compliance. PROFESSIONAL EXPERIENCE

Sep 2023 –

Jan 2025

Regulatory Affairs Diagnostics, International Strategics SubChapter Roche Services (Europe) Ltd., Budapest, Hungary

● RoW submissions and managed data in Veeva Vault (RIM MedTech), SAP and manage Health Authority Q&A / HA Interactions

● Executed regulatory protocols and GAP analyses to improve global cross-functional processes

Partnered with R&D, Quality, and Commercial teams to reduce regulatory risks and accelerate submissions

● Familiar with ISO 13485, mQMS, EU MDR, IVDR, Regulatory Intelligence / Change Tracking

● Beginner with FDA Quality System Regulation

Jan 2022 –

Jan 2023

Research Assistant Technician, Page Lab

Whitehead Institute for Biomedical Research, Cambridge, MA

● Supported studies with Harvard Medical School, MIT and Boston Children’s Hospital

● Organized and analyzed participant data, ensuring regulatory and ethical compliance

● Prepared SOPs, reviewed protocols, and ensured documentation integrity

● Managed sensitive records and contributed to hormone and genetic disorder research

Aug 2020 –

Aug 2021

Laboratory Analyst, GenoID Molecular Diagnostic Laboratory Roche Services (Europe) Ltd., Budapest, Hungary

● Operated and executed COVID RNA isolation, PCR, and STD tests, contributing to timely and accurate diagnosis

● Maintained patience documentation and supported lab compliance activities, ensuring audit readiness and regulatory adherence Jan 2022 –

Jan 2023

Laboratory Assistant, Inorganic Chemistry Department University of Veterinary Medicine, Budapest, Hungary

● Conducted research on endocrine disruptors’ effects on brain cells, advancing understanding of neurotoxicity

Jan 2016 –

Oct 2017

Student Laboratory Assistant, MolBio- and Food Engineer Department University of Szeged, Szeged, Hungary

● Conducted food microbiology and analytical chemistry testing to ensure product safety and quality compliance.

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EDUCATION

2018-2020 Master of Science in Biotechnology

● MATE - Hungarian University of Agriculture and Life Sciences

● Godollo, Hungary

2018-2020 Bachelor of Science in Food Science / Food Engineer

● University of Szeged

● Szeged, Hungary

FURTHER EDUCATION

2021-2022 Applied Data Science, Certification

MIT Professional Education

PROJECT EXPERIENCE

2024

2024

Change Management Automation Bot

Onboarding Website for Regulatory Affairs

LANGUAGES

● Hungarian (mother tongue)

● English (fluent)

IT KNOWLEDGE

● Microsoft Office (Word, Excel, PowerPoint, Outlook) – advanced Slack, Teams, Zoom, Gmail – advanced

● Veeva Vault (RIM MedTech), SAP – intermediate

SharePoint, Smartsheet / Monday.com, DocuSign, Adobe Acrobat Pro – intermediate Trello, OneNote, LucidChart / LucidSpark – intermediate

● PyCharm, Jupyter Notebook / JupyterLab, Google Colab, Google Data Studio – beginner REFERENCES

Available upon request

PUBLICATIONS

Independent effects of testosterone, estradiol, and sex chromosomes on gene expression in immune cells of trans- and cisgender individuals, Oct 9, 2024 Page 2 of 2

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