Background of Marianne Thuen Jakobsen
I have a background as Regulatory Affairs Specialist and Patent Specialist at Cheminova A/S in Denmark (acquired by FMC in 2015). As a Regulatory Affairs Specialist, I have worked with countries all over the world, and with many different responsibilities like managing a.i.’s, area responsibilities, dossier preparation, summary writing used in Annex II and Annex III dossiers, liaison with local authorities, consultants and distributors, coordinating the transfer of product authorisation after an acquisition, projects, business strategies etc.
I hold a Master in Pharmaceutical Chemistry and pharmaceutical products do also have my interest. My main experience lies
During my employment at Cheminova A/S, I worked as QA Specialist for two years in a certified GLP phys/chem laboratory. As Manna Regulatory, I have joined Cheminova A/S again for another two years to act as internal auditor before and during the transfer of the GLP lab from Rønland to Copenhagen.
Main focus within Regulatory Affairs
My focus has mainly been on East and Southern Africa, as well as the Middle East and Asia. I have also worked with countries in Central America, CIS and EU. In the EU, the main area of expertise is the North Zone, especially Denmark, Sweden, and Norway.
The recent years, the main focus has been on the Nordic and Baltic countries in the North zone of EU, but also the Central and South zones.
Characteristics of Manna Regulatory
I believe in doing things “by the book” and set high standards for the outcome of my work. I am meticulous with respect to the presentation of data to the authorities and master the ability to stay organized and meet deadlines on time.
I meet local authorities with mutual respect and integrity in order to understand the requests and guidance during the approval process. Contact with customers is likewise based on trust and credibility.
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