Mona Frimann Larsen

-  a unique combination of Regulatory and Operational experience 

"Nothing beats a good process!"

 https://www.linkedin.com/in/monalarsen/

CV

Vantage GMP & Labelling, Founder and Principal Advisor/Senior Consultant, Current

Novo Nordisk, Global Regulatory Affairs, Novo Nordisk Labelling Process Manager, 2021-2026

Responsible for the end-to-end process for development and lifecycle management of labelling, including:

  • the Company Core Data Sheet (CCDS) and local labelling
  • colour and graphics development and artwork management
  • electronic Product Information (ePI)
  • process and data across IT systems, i.e. Veeva RIM, AMS (Esko) and ERP (SAP)

Vice-chair, Novo Nordisk Secondary Packaging Material Intelligence Group responsible for assessment of new external requirements, such as EMA and FDA.

Novo Nordisk Production, oral pack, Senior Professional and area process manager, 2017-2021

Project manager, validation and GMP SME. Established and headed-up packaging and serialisation process group across Oral Pack in Novo Nordisk. Representing the area in Secondary Packaging Intelligence group assessing new regulatory requirements.

Novo Nordisk CMC Development, Senior Project Coordinator, 2012-2017

Project manager and validation responsible. In the period I was there the area expanded with two packaging lines i and a large storage (+150 pallets places). I was involved as project manager and/or validation responsible in all projects with budget upto ~50 MDKK. Besides this I standardised the areas validation concept.

Dako (Agilent Technologies) Production,  Project manager and support chemist, 2007-2012

I worked with optimisation and CAPEX projects within labelling and filling. Stationed seven months at the Dako US site. Worked with production transfer of Japanese labelling from Japan to Denmark.

Chemotec A/S, Biologist, 2007

Laboratory responsible, I achieved getting the laboratories, after three years dormancy, approved for GMO cell culturing . 


I enjoy working independently, planning my own day. I thrive working with others for professional input and good laughs.

I spend my free time with my family and friends, and I love outdoor sport activities.

For more details, refer https://www.linkedin.com/in/monalarsen