Katrine Rosted Hansen

Katrine Rosted Hansen Email and Phone Number

Head of Regulatory Affairs @ Oresund Pharma ApS
copenhagen, capital region, denmark
Katrine Rosted Hansen's Location
Capital Region of Denmark, Denmark, Denmark
About Katrine Rosted Hansen

As leader my main focus is to define the right strategies, help paving the way and ensuring the right development.My experience with Regulatory Affairs includes expertise in European pharmaceutical framework, legislation and regulation; amd experience with regulatory strategy reviews, dossier review/audit, handling of DCP and national phase for Nordic countries and project work with managing multiple stakeholders.Previous experience includes regulatory launch mangement.Additionally, I have experience from Regulatory Business Support and document management (EDMS).As a person, I am enthusiastic, approachable and social. I have a passion for IT and am quite skilled therein. Furthermore, I am a go-getter and like a good professional work environment with room for "fun and games".

Katrine Rosted Hansen's Current Company Details
Oresund Pharma ApS

Oresund Pharma Aps

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Head of Regulatory Affairs
copenhagen, capital region, denmark
Employees:
5
Katrine Rosted Hansen Work Experience Details
  • Oresund Pharma Aps
    Head Of Regulatory Affairs
    Oresund Pharma Aps Oct 2024 - Present
  • Sandoz
    Regulatory Affairs Manager, Teamleader Lcm
    Sandoz May 2020 - Oct 2024
    København, Hovedstaden, Danmark
    Teamleader for Regulatory Life Cicle Managment team responsible for all 5 Nordic countries
  • Sandoz
    Regulatory Affairs Manager, Licensing (Bdl)
    Sandoz Oct 2016 - Apr 2020
    Copenhagen Area, Denmark
    RA Manager Licensing (BDL), NordicsResponsible for regulatory handling of BDL projects incl. dossier review, regulatory strategies, MAA applications, HA correspondence, launch management and lifecycle activities.
  • Sandoz
    Regulatory Affairs Manager, Launch
    Sandoz Mar 2015 - Sep 2016
    Copenhagen Area, Denmark
    RA Launch Manager for Nordics with assigned own portfolio to ensure regulatory national market readiness. Responsible for RA launch readiness.
  • Sandoz
    Regulatory Affairs Officer, Launch
    Sandoz Nov 2013 - Feb 2015
    Regulatory responsible for Nordic countries to ensure handling of MAA on national level
  • Takeda Pharmaceuticals (Former Nycomed)
    Regulatory Information Manager, Global Regulatory Affairs
    Takeda Pharmaceuticals (Former Nycomed) Aug 2012 - Oct 2013
    Roskilde
    Responsible for global EDMS Regulatory Business Support, incl. business development/URS of new EDMS solution.
  • Gubra
    Research Associate
    Gubra Feb 2012 - Jul 2012
    Hørsholm
    Maternity cover.
  • Parken Sport & Entertainment A/S
    Hostess
    Parken Sport & Entertainment A/S Apr 2008 - 2012
    Copenhagen Area, Denmark
  • University Of Arkansas For Medical Sciences
    Master Thesis Graduate
    University Of Arkansas For Medical Sciences Feb 2011 - Aug 2011
    Department Of Neurology
    Master’s thesis project in collaboration with University of Arkansas for Medical Science focused on neurologic deficits in relation to diabetes (hyperglycaemia). The work has subsequently been published in Neurochemistry International.
  • Dagens Medicin
    Student Employee
    Dagens Medicin Apr 2007 - Feb 2011
    Copenhagen Area, Denmark
    Student worker, Misc tasks.
  • Birkerød Apotek
    Intern
    Birkerød Apotek Feb 2010 - Jul 2010
    Pharmacy internship - cand.jus.

Katrine Rosted Hansen Education Details

Frequently Asked Questions about Katrine Rosted Hansen

What company does Katrine Rosted Hansen work for?

Katrine Rosted Hansen works for Oresund Pharma Aps

What is Katrine Rosted Hansen's role at the current company?

Katrine Rosted Hansen's current role is Head of Regulatory Affairs.

What schools did Katrine Rosted Hansen attend?

Katrine Rosted Hansen attended Københavns Universitet / University Of Copenhagen, Københavns Universitet / University Of Copenhagen.

Who are Katrine Rosted Hansen's colleagues?

Katrine Rosted Hansen's colleagues are Svend Johansen, Patrick Cohn Johansen, Markus Dehnhardt, Phd, Søren Høgh, Elizabeth Stub Halborg.

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