Summary
Overview
Work History
Education
Skills
Timeline
Generic
LÍVIA SIKLÓSI-SIMON

LÍVIA SIKLÓSI-SIMON

Regulatory Professional
Dunakeszi,PE

Summary

Experienced Regulatory Affairs professional with 10 years of expertise in EU pharmaceutical registration for Rx and OTC products. Proven track record in overseeing regulatory activities across product lifecycle, with a focus on DCP procedures, market expansion strategies, and portfolio development in the EU market. Skilled in managing regulatory submissions, engaging with authorities, and ensuring compliance for promotional materials directed at healthcare professionals and consumers. Capable of fostering cross-functional collaboration, leading teams, and navigating complex regulatory environments. Committed to driving innovation, maintaining compliance standards, and delivering timely regulatory solutions for business success.

Overview

16
16
years of professional experience
2
2
Languages

Work History

Regulatory Lead Pain Category CEE zone

Opella Healthcare Commercial
01.2024 - Current
  • Coordination of innovation projects for pain relief products within the CEE region

Country Regulatory Lead

Opella Healthcare Commercial
11.2023 - Current
  • Responsible for leading full lifecycle management of the portfolio (OTC medicines, food supplements and medical device)
  • Managing new Marketing Authorization procedures in Hungary
  • Strong cross-functional collaboration with the Business Development department, Brand Managers and Global Regulatory and Medical to optimize the CEE region's goals
  • Provide regulatory input in the creation and approval of promotional content targeting HCPs and consumers.
  • Liaising with Health Authority, industry associations, and external stakeholders to ensure compliance and alignment.

Regulatory Manager

Opella Healthcare Commercial-Sanofi CHC
11.2022 - 11.2023
  • Responsible for lifecycle management of Allegra, Dulcolax, Magne B6
  • Responsible for new marketing authorization in Hungary (Metamizole film-coated tablets and oral drops)
  • Member of cross-functional teams with medical, PV, quality and brand manager team

Senior Regulatory Affairs Specialist and Registration Manager

Egis Pharmaceuticals Plc.
08.2021 - 10.2022
  • Specialised in writing, editing and supervising the Product Information documents (SmPC, PL and labelling)
  • Managed end-to-end DCP procedures to enable portfolio growth in the central nervous system and dietetics therapeutic areas within the EU.
  • Labelling working group team leader, coordination of safety regulatory projects and variations, ensure the safety compliance

Regulatory Affairs Associate and Registration Manager

Egis Pharmaceuticals Plc.
11.2019 - 07.2021
  • Full lifecycle management of RX and OTC products

Regulatory Affairs Associate

Richter Gedeon Plc.
08.2016 - 11.2019
  • Department of Regulatory Compliance, Product Information

Pharmacist and Deputy Head Pharmacist

Margit and Palánk Pharmacies
07.2009 - 07.2016

Education

Postgradual degree - Pharmacology

Semmelweis University

Bachelor degree - Pharmacy

Semmelweis University

Skills

Cross-functional collaboration

Timeline

Regulatory Lead Pain Category CEE zone

Opella Healthcare Commercial
01.2024 - Current

Country Regulatory Lead

Opella Healthcare Commercial
11.2023 - Current

Regulatory Manager

Opella Healthcare Commercial-Sanofi CHC
11.2022 - 11.2023

Senior Regulatory Affairs Specialist and Registration Manager

Egis Pharmaceuticals Plc.
08.2021 - 10.2022

Regulatory Affairs Associate and Registration Manager

Egis Pharmaceuticals Plc.
11.2019 - 07.2021

Regulatory Affairs Associate

Richter Gedeon Plc.
08.2016 - 11.2019

Pharmacist and Deputy Head Pharmacist

Margit and Palánk Pharmacies
07.2009 - 07.2016

Bachelor degree - Pharmacy

Semmelweis University

Postgradual degree - Pharmacology

Semmelweis University
LÍVIA SIKLÓSI-SIMONRegulatory Professional