Katrine Rosted Hansen Email and Phone Number
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".
Oresund Pharma Aps
View- Website:
- oresundpharma.com
- Employees:
- 5
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Head Of Regulatory AffairsOresund Pharma Aps Oct 2024 - Present -
Regulatory Affairs Manager, Teamleader LcmSandoz May 2020 - Oct 2024København, Hovedstaden, DanmarkTeamleader for Regulatory Life Cicle Managment team responsible for all 5 Nordic countries -
Regulatory Affairs Manager, Licensing (Bdl)Sandoz Oct 2016 - Apr 2020Copenhagen Area, DenmarkRA Manager Licensing (BDL), NordicsResponsible for regulatory handling of BDL projects incl. dossier review, regulatory strategies, MAA applications, HA correspondence, launch management and lifecycle activities. -
Regulatory Affairs Manager, LaunchSandoz Mar 2015 - Sep 2016Copenhagen Area, DenmarkRA Launch Manager for Nordics with assigned own portfolio to ensure regulatory national market readiness. Responsible for RA launch readiness. -
Regulatory Affairs Officer, LaunchSandoz Nov 2013 - Feb 2015Regulatory responsible for Nordic countries to ensure handling of MAA on national level -
Regulatory Information Manager, Global Regulatory AffairsTakeda Pharmaceuticals (Former Nycomed) Aug 2012 - Oct 2013RoskildeResponsible for global EDMS Regulatory Business Support, incl. business development/URS of new EDMS solution. -
Research AssociateGubra Feb 2012 - Jul 2012HørsholmMaternity cover. -
HostessParken Sport & Entertainment A/S Apr 2008 - 2012Copenhagen Area, Denmark
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Master Thesis GraduateUniversity Of Arkansas For Medical Sciences Feb 2011 - Aug 2011Department Of NeurologyMaster’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. -
Student EmployeeDagens Medicin Apr 2007 - Feb 2011Copenhagen Area, DenmarkStudent worker, Misc tasks. -
InternBirkerød Apotek Feb 2010 - Jul 2010Pharmacy internship - cand.jus.
Katrine Rosted Hansen Education Details
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Pharmaceutical Sciences -
Pharmaceutical Sciences
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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