Monika Freudenreich

VP Regulatory at StethoMe

Monika Freudenreich has extensive experience in the regulatory affairs field. Monika is currently working as the VP Regulatory at StethoMe ® since March 2021. Prior to this, they worked at LiNA Medical from March 2017 to February 2021 as a Regulatory Affairs Officer. Monika'sresponsibilities included preparing regulatory documentation for medical device registration, supporting regulatory activities for Rest of the World markets, maintaining standards listings, coordinating regulatory changes, and managing labels and IFUs.

Before their time at LiNA Medical, Monika worked at GSK from June 2013 to February 2017 as a Regulatory Affairs Specialist. Monika'stasks involved preparing CMC documentation for international markets, compiling dossiers, gathering supporting documentation, reviewing and approving global CMC applications, renewing drug product licenses, assessing planned changes, and preparing variations dossiers. Monika started their career at GSK as a Junior Regulatory Affairs Specialist from February 2010 to May 2013.

Monika Freudenreich completed their education with a Master's Degree in Biotechnology from Uniwersytet Przyrodniczy w Poznaniu, from 2004 to 2009. Monika then pursued postgraduate studies in Quality, Environmental and Product Safety Management at Uniwersytet Przyrodniczy w Poznaniu from 2009 to 2010. In 2011 to 2012, Monika attended Poznan University of Economics And Business for postgraduate studies in Strategic Marketing in Pharmaceutical Industry. Additionally, they have obtained a Certificate in Advanced English (CAE) from the University of Cambridge Local Examinations Syndicate, although the specific month and year of obtaining the certificate are not provided.

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Timeline

  • VP Regulatory

    March, 2021 - present